document control medication guidelines for chronic heart ... · version date issued status comment...

Medication Guidelines for Chronic Heart Failure due to Reduced Ejection Fraction (HF-REF)

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Document Control

Title


Author

Author’s job title Lead Nurse for Cardiac Support Services

Directorate Acute

Department Cardiology – Cardiac Support Services

Version Date

Issued Status Comment / Changes / Approval

1.0

Mar 2004

Draft Authorship date

1.1 Jul 2007

Revision Revised document

2.0 May 2017

Final Approved by Drugs & Therapeutic Committee Amendments made to bring guideline up to date with evidence based treatment of chronic heart failure as reflected in NICE guidance and technological appraisals

Main Contact Lead Nurse for Cardiac Support Services, Cardiology suite, level 1 North Devon District Hospital Raleigh Park Barnstaple, EX31 4JB

Tel: Direct Dial – 01271 335945

Lead Director Director of Unplanned Care

Superseded Documents Treatment Guidelines for Chronic Heart Failure due to LVSD

Issue Date May 2017

Review Date May 2020

Review Cycle Three years

Consulted with the following stakeholders:

Consultant Cardiologist team Non-Medical Prescribing lead Cardiology Operational Group Heart Failure Nurse Specialist team Pharmacist for Cardiology

Approval and Review Process

Cardiology Operational Group Drugs & Therapeutic group

Local Archive Reference G:\HEART FAILURE\Heart Failure Main File\POLICIES & GUIDELINES\HEART FAILURE\TREATMENT GUIDELINES\Medication Guidelines for Chronic Heart Failure due to Reduced Ejection Fraction (HF-REF) - FINAL 2017.docx Filename



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Policy categories for Trust’s internal website (Bob) Cardiology, Pharmacy

Tags for Trust’s internal website (Bob) Chronic Heart Failure, Heart Failure, Cardiology, Systolic Dysfunction, Reduced Ejection Fraction, Diuretic Management, Ace inhibitor, Beta-blocker, Ivabradine, Sacubitril, Valsartan, Spironolactone, Eplerenone, Mineralocorticoid antagonist



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CONTENTS

Document Control ............................................................................................................................ 1

1. Purpose ..................................................................................................................................... 4

2. Definitions................................................................................................................................. 5

3. Responsibilities ......................................................................................................................... 5

Role of Consultant Cardiologist .................................................................................................. 5

Role of Lead Heart Failure Clinical Nurse Specialist .................................................................... 6

Role of Heart Failure Clinical Nurse Specialist ............................................................................ 6

4. Medication Guidelines .............................................................................................................. 7

Algorithm for the introduction & titration of ACE Inhibitor or Angiotensin Receptor Blocker, if intolerant to ACE-Inhibitor......................................................................................................... 8

ACE-I / ARB in HF-REF ................................................................................................................ 9

Algorithm for the use of Beta-Blockers in Heart Failure............................................................ 10

Beta-blockers in HF-REF ........................................................................................................... 11

Algorithm for the use of Mineralocorticoid / Aldosterone Receptor Antagonist (MRA) ............ 13

Mineralocorticoid Receptor Antagonist in HF-REF .................................................................... 14

Algorithm for the use of Sacubitril/Valsartan - Angiotensin Receptor Neprilysin Inhibitor (ARNI) ................................................................................................................................................ 15

Sacubitril / Valsartan in Chronic Heart Failure due to HF-REF ................................................... 16

Dosing schedules – Sacubitril / Valsartan ................................................................................. 17

Algorithm for the use of Ivabradine in Heart failure & Sinus Rhythm ....................................... 18

Ivabradine in Chronic Heart Failure due to HR-REF................................................................... 19

Algorithm for the initiation of diuretic therapy ........................................................................ 20

Algorithm for Diuretic Titration ............................................................................................... 21

Diuretic Management in patients with chronic heart failure .................................................... 23

Algorithm for the use of Combination Diuretic Therapy ........................................................... 24

Combination therapy with Loop & Thiazide Diuretic ................................................................ 25

Algorithm for the use of Digoxin in Heart failure ...................................................................... 27

Digoxin in Chronic Heart Failure due to LVSD ........................................................................... 28

Cardiac resynchronisation Therapy (CRT-P / CRT-D) ................................................................. 29

Algorithm for Management of Hypokalaemia .......................................................................... 31

5. Algorithm for Non-pharmacological management .................................................................. 33

6. Depression & Anxiety .............................................................................................................. 34

7. End of life care ........................................................................................................................ 34

8. Monitoring Compliance with and the Effectiveness of the Guideline ..................................... 34

Standards/ Key Performance Indicators ................................................................................... 34

Key performance indicators comprise: ..................................................................................... 34

9. Equality Impact Assessment.................................................................................................... 35

10. References .............................................................................................................................. 35



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1. Purpose

1.1. The purpose of this document is to support the Heart Failure Clinical Nurse Specialist (HFN) to initiate and adjust specific heart failure medications, for the purpose of symptom control and optimisation of evidence based medicine. This document will include detailed protocols recommended by the National Institute for Clinical Excellence (NICE) for Adults with Chronic Heart Failure. It is not considered exclusive and should be used in conjunction with the British National Formulary (BNF) and the North & East Devon Formulary.

1.2. The policy applies to Heart Failure Clinical Nurse Specialist Team.

1.3. The guidance takes the form of a series of algorithms supporting the optimal pharmacological and non-pharmacological management of chronic heart failure due to reduced ejection fraction (HF-REF) formerly called left ventricular systolic dysfunction (LVSD).

1.4. The management of heart failure with normal systolic function, namely heart failure due to preserved ejection fraction (HF-PEF), is not covered in this policy.

1.5. In accordance with the Trust’s Medicine Policy 2015 and Non-Medical Prescribing Policy 2016, HFNs using this guideline must hold a non-medical independent or supplementary prescribing qualification and be registered on the Trust’s prescribers’ list.

1.6. Implementation of this policy will ensure that:

Only appropriate patients, who have received an echocardiogram confirming HF-REF, and have been reviewed by a cardiologist, to confirm diagnosis of heart failure and consider possible causes and treatment options, are reviewed by the HFN specialist team. QS9 Chronic Heart Failure In Adults (2016) Quality Statement 1.

All suspected heart failure referred from primary care will follow the Suspected Heart Failure Pathway

For those patients referred directly to the HFN specialist team, with a previously confirmed diagnosis of HF-REF, the HFNs will review the patient’s medical records and where appropriate discuss the patient’s management with Cardiologist team prior to accepting the referral. This is to ensure all patients are scrutinised for underlying aetiology and appropriate subsequent on-going investigation and treatment.

All patients referred to the HFNs will be assessed with regard to suitability for initiation and optimisation of appropriate diuretics including aldosterone antagonists and ACE inhibitors, beta-blockers, Digoxin and Ivabradine according to NICE recommendations. QS9 Chronic Heart Failure in Adults (2016) Quality Statement 3. If there is any doubt, certain treatments will be discussed with the Consultant Cardiologist or GP

HFNs will also consider the therapeutic option of adding Sacubitril / Valsartan, in place of an ACE / ARB, in line with national (TA388) and local guidance and where considered suitable refer to cardiologist.

Once heart failure medications have been optimised, and / or where patient’s symptoms have changed, the HFN will review potential suitability for device therapy and where patient appears to meet criteria will refer back to cardiologist team.

http://ndht.ndevon.swest.nhs.uk/cardiology/suspected-heart-failure-referral-proforma/

http://ndht.ndevon.swest.nhs.uk/cardiology/suspected-heart-failure-referral-proforma/



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Patients will be reviewed within 2 weeks of medication change to monitor effects. This will be conducted as either a face to face or telephone assessment and may include blood test monitoring. QS9 Chronic Heart Failure In Adults (2016) Quality Statement 4.

All treatment recommendations will be communicated to all relevant health care professionals and recorded in the heart failure notes. Letters will be copied to patients routinely unless they decline.

All patients referred to the HFN clinic will receive information on the nature of heart failure, drug regimes, adverse reactions, dietary restrictions, symptoms of worsening heart failure, what to do if these symptoms occur and prognosis. This will be an on-going process allowing patients and their families / carers time to absorb information, formulate questions and promote self-monitoring in managing this long term condition.

All patients will be given a copy of HF nurse contact details and service information leaflet. In addition, they will be given a copy of the British Heart Foundation’s ‘An everyday guide to living with heart failure’ to include a progress booklet to promote self-monitoring .

2. Definitions

2.1. LVSD – Left Ventricular Systolic Dysfunction

2.2. HF-REF – Heart Failure with reduced Ejection Fraction

2.3. HF-PEF – Heart Failure with preserved Ejection Fraction

2.4. HFN – Heart Failure Nurse

2.5. ARNI – Angiotensin II Receptor Neprilysin Inhibitor (Sacubitril / Valsartan)

2.6. CRT-D – Cardiac-Resynchronisation Therapy – Defibrillator

2.7. CRT-P Cardiac-Resynchronisation Therapy – Pacemaker

2.8. NMP – Non Medical Prescribing

2.9. ACE-I – Ace-Inhibitor

2.10. ARB – Angiotensin II Receptor Blocker

2.11. BB – Beta-blocker

2.12. MRA – Mineralocorticoid Receptor Antagonist

2.13. OMT – Oral Medical Therapy

3. Responsibilities

Role of Consultant Cardiologist

3.1. The Consultant Cardiologist is responsible for:



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Confirming heart failure diagnosis and referring suitable patients to the heart failure nurse service

Retaining clinical responsibility for their patients care while using the heart failure nurse service

Providing clinical support to the heart failure clinical nurse specialist for the patients being managed within the service

Role of Lead Heart Failure Clinical Nurse Specialist

3.2. The Lead Heart Failure Clinical Nurse Specialist is responsible for:

Ensuring that the service is delivered adhering to local and national guidelines, ensuring these are regularly reviewed and updated in accordance with the evidence base.

Providing clinical support in the on-going professional education and development to the Heart Failure Nurse Service.

Ensuring that all staff within the Heart Failure Nurse Service adhere to the current policy and legislation i.e.

Medicines policy NMP policy NMC codes of professional conduct Organisational policy

Ensuring that all staff within the Heart Failure Nurse Service work within their field of competency. All appropriate competencies are discussed at appraisal and evaluated and documented accordingly.

Role of Heart Failure Clinical Nurse Specialist

3.3. The Heart Failure Clinical Nurse Specialist is responsible for:

Working in line with the NMC code of professional standards of practice and behaviour, being responsible and accountable for their sphere of clinical skills

Ensuring that they work within current legislation and the organisation's Medicine Policy and Formularies.

Following their professional codes of practice and remaining accountable for prescribing practice at all times. Attending at least 2 Non Medical Prescribing forums annually

Identifying learning needs, meeting their Continuing Professional Development requirements, and ensuring that they are up to date on the conditions for which they prescribe.

Only practicing within their competence.

Regularly undertaking audit of their prescribing.

Acting as an expert resource to others (including patients and other professionals).

Following this policy as a guide to prescribing, but may prescribe outside of this policy, while clearly documenting their decision making process.



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4. Medication Guidelines

The Therapeutic Algorithm for a patient with symptomatic heart failure with reduced systolic function (HFrEF) ESC (2016) will be utilsed to optimise pharmacology for this patient group.



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Algorithm for the introduction & titration of ACE Inhibitor or Angiotensin Receptor Blocker, if intolerant to ACE-Inhibitor

Confirmed HF-REF

Suitable for initiation of Angiotensin Converting Enzyme (ACE-I) Or Angiotensin Receptor Blocker (ARB), if intolerant of ACE-I?

Step 1 – Initiation of ACEI or ARB

Stop potassium supplements / potassium sparing diuretics (hyperkalaemia risk) with the exception of Spironolactone / Eplerenone

Stop ‘Lo-salt’ substitutes

If possible, stop NSAID (⬆risk of renal dysfunction)

Discuss benefits and possible adverse effects of therapy (i.e. dizziness, cough)

Check renal function

Start with low dose (see dosing schedule)

North & East Devon Formulary

1st line ACEI – Ramipril, Lisinopril, Enalapril

1st line ARB - Candesartan

Cautions / Seek consultant advice:

Significant hyperkalaemia (K > 5.0 mmol/L)

Significant renal dysfunction (creatinine > 200umol/L or eGFR < 30)

Symptomatic or severe hypotension (SBP <90mmHg)

Contraindications:

History of angioedema

Known bilateral artery stenosis

Pregnancy / risk of pregnancy

Known allergic reaction / adverse reaction

Step 2 – Review after 1 – 2 weeks

Check U&Es at 10 – 14 days

Check for adverse effects o Symptomatic hypotension o Creatinine rises > 30% / > 200mmol/l o Serum K > 5.5mmol/L o Intolerable cough (exclude pulmonary

oedema)

Double dose (or smaller increment if indicated) if no adverse effects and renal function stable

Repeat step 2 aiming for target or highest tolerated dose

IF ADVERSE EFFECTS SEE **BOX

**ADVERSE EFFECTS

Intolerable cough o consider switching to equivalent dose of ARB

Symptomatic hypotension o Consider changing to evening dose o Consider diuretic reduction if not fluid

overloaded o Consider need for nitrates, calcium channel

blockers and other vasodilators, reducing / stopping dose if possible

o If no other cause, reduce or stop ACEI / ARB

Hyperkalaemia / worsening renal function

Some decline in renal function is acceptable - creatinine increase of 30% or up to 200mmol/L, whichever smaller is acceptable. An increase of serum K <5.5mmol/L is acceptable

If urea, creatinine or serum K rise excessively: o consider diuretic reduction if not fluid overloaded o Stop NSAID where possible o Consider halving dose of ACE-I / ARB

Stop ACE-I / ARB if serum K rises > 5.5mmol/L, creatinine increase >100% and liaise with consultant cardiologist / GP.

Serial monitoring of U&Es should be undertaken until parameters are satisfactory & have stabilised.



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ACE-I / ARB in HF-REF

ACE-Is have been shown to improve survival in patients with HF-REF and are recommended for every patient, with this condition, unless contraindicated or not tolerated. ARBs have not been consistently proven to reduce mortality and should be restricted to those intolerant of an ACE-I. (ESC 2016) ACE-I are generally initiated before or alongside a beta-blocker, but clinical judgement should be used when deciding which drug to adjust e.g. beta-blocker titration may take priority in the presence of arrhythmia / angina.

Advice for patients taking ACE-I / ARB therapy:

Explain expected benefits of ACE-I / ARB:

treatment is given to improve symptoms, reduce the deterioration of heart failure and to

increase survival.

Advise that symptoms may improve within a few weeks to months.

Advice of potential adverse events / effects to report: dizziness / collapse (possible hypotension

or rhythm disturbance), swelling of throat / tissues (angioedema) and dry cough. Dizziness,

blackouts or lightheadedness may be signs of cerebral hypoperfusion. Other possible side effects

may include rash, GI symptoms, upper respiratory symptoms (sinusitis, rhinitis, sore throat).

Patient advised to stop ACE-I /ARB immediately and seek urgent review if tongue / throat

swelling occurs.

Stress importance of regular U & Es following initiation and titration to monitor renal function.

Provide contact details and symptom monitoring information leaflet.

Dosing Schedules – ACE-I / ARB

Drug ENALAPRIL LISINOPRIL RAMIPRIL Candesartan

Week 1 Starting Dose

2.5mg twice daily 5mg daily 1.25mg daily 4mg daily

3 5mg twice daily 10mg daily 2.5mg daily 8mg daily

5 10mg twice daily 20mg daily 5mg daily 16mg daily

7 15mg twice daily 20mg daily* 10mg daily* 32mg daily*

9 10 - 20mg in 1 or 2 divided doses*

*Target dose

**Patients on large doses of diuretics or frail / elderly patients, consider halving the initiating dose.



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Algorithm for the use of Beta-Blockers in Heart Failure

Confirmed HF-REF

Suitable for initiation of beta-blocker?

Review medical history and identify if any current contra-indications

Step 1 – Assess whether suitable for treatment

Absent or stable signs of fluid retention

HR > 60bpm,

SBP > 100mmHg

1st degree AV block (d/w cardiologist)

Contraindications:

History of asthma or Chronic Obstructive Pulmonary Disease (COPD) with reversibility

Patients with diabetes mellitus who experience frequent hypoglycaemic episodes.

Cardiac conduction disturbances - Sick sinus syndrome, 2nd and 3rd degree atrio-ventricular (AV) block

Severely symptomatic unstable heart failure (NYHA class IV)

Cardiogenic shock

Significant renal or hepatic dysfunction

Prinzmetal angina

Pregnancy / breastfeeding **Please refer to BNF for full list or contra-indications / interactions before initiating a beta-blocker

Step 2 – Initiation of beta-blocker

Start with lowest recommended dose

Educate patients re: purpose, benefits and symptom monitoring

Consider reducing other rate reducing medication


Bisoprolol – first line

Carvedilol

Nebivolol*

*Formulary position to reserve for patients intolerant of other beta-blockers

Step 3 – Review and dose increment

Review clinical status 1 – 2 weeks

Check for & manage adverse effects

If HR > 60bpm & SBP > 100mmHg and heart failure signs & symptoms are stable, consider dose increase

Up-titrate beta-blocker according to dosing schedule

Aim for target or maximum tolerated dose

Check U&E 1 – 2 weeks after initiation and final dose titration

IF ADVERSE EFFECTS SEE **BOX

**ADVERSE EFFECTS

Marked fatigue o Consider switching to Nebivolol o Consider halving dose of beta-blocker -

review 2 weeks

Worsening congestion o consider adding / increasing loop diuretic o if serious consider halving or stopping beta-

blocker

Symptomatic hypotension o Consider changing to evening dose o Consider diuretic reduction if not fluid

overloaded o Consider need for nitrates, calcium channel

blockers and other vasodilators, reducing / stopping dose if possible

o If no other cause, reduce or stop ACEI / ARB or beta-blocker

Bradycardia <50bpm o Obtain ECG o Consider decreasing other rate reducing

medication o Arrange ECG to exclude heart block – liaise

with cardiologist o Consider reducing / stopping beta-blocker



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Beta-blockers in HF-REF

Beta-blockers reduce mortality and morbidity in symptomatic patients with HF-REF, despite treatment with an ACE-I. Beta –blockers should be initiated in clinically stable patients at a low dose and gradually up-titrated to a maximum tolerated dose. (ESC 2016)

Which Beta-blocker?

Bisoprolol – stable chronic moderate to severe heart failure (NYHA class II – IV) with reduced ejection fraction. More cardio-selective than carvedilol, therefore may be choice for patients with co-morbid respiratory disease. Once daily dose, hepatic & renal excretion

Carvedilol – Stable mild to moderate chronic heart failure (NYHA I – III). Twice daily dose mainly hepatic excretion.

Nebivolol – highest degree of cardio-selectivity. May be useful where other beta-blockers are not tolerated due to increased symptoms of fatigue or breathlessness.

Advice for patients taking Beta-blockers

Explain expected benefits of beta-blockers: to improve symptoms, reduce risk of hospital

admission and increase survival.

Explain that symptoms may improve slowly over 3 – 6 months or longer.

Inform of possible temporary deterioration in condition, which can be easily managed by

adjustment of other medications – advise them to report worsening symptoms (breathlessness,

tiredness, fatigue) to HFN / GP.

Advise patient not to stop beta-blocker therapy without consulting HFN / GP.

Encourage patients to weigh themselves daily and report significant weight gain (i.e. greater

than 1kg / day for 2 consecutive days).

Tiredness can feel worse while up-titrating beta-blockers, but should improve within a few days

/ weeks of each up-titration.

Patients with diabetes are encouraged to monitor BMs regularly and discuss problems with their

GP / diabetic nurse.

Provide contact details and symptom monitoring information leaflet.



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Dosing schedules – Beta-blocker

Drug Carvedilol Bisoprolol Nebivolol

Starting Dose 3.125mg twice daily 1.25mg daily 1.25mg daily

Week 3 6.25mg twice daily 2.5mg daily 2.5mg daily

Week 5 12.5mg twice daily 3.75mg daily 5mg daily

Week 7 25mg twice daily* 5mg daily 10mg daily

Week 9 50 mg twice daily† 5mg daily

Week 11 7.5mg daily

Week 15 10mg daily

*Target dose in patients less than 85kg †Target dose in patients greater than 85kg



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Algorithm for the use of Mineralocorticoid / Aldosterone Receptor Antagonist (MRA)

If clinically unstable

Confirmed HF-REF

Symptomatic heart failure (NYHA class II – IV)

Step 1 – assess whether suitable for treatment:

Symptomatic heart failure (NYHA class II – IV)

Already on optimum pharmacological treatment

Consider if clinically overloaded despite treatment with loop diuretic therapy

No evidence of hypovolaemia

Serum K <5mmol/l

Creatinine < 200mmol/l

Inform patient of potential benefits & adverse effects

Contra-indications:

Serum K >5mmol/l

Serum Creatinine > 220

Caution if mild to moderate renal impairment (consider lower dose of 12.5mg daily)*

Caution in the frail / elderly patient, particularly if also taking an ACE-I or ARB*

Addison’s disease

Step 2 – Initiation of Spironolactone / Eplerenone

Consider stopping K supplements / K sparing diuretic

Start with low dose (12.5* – 25mg daily)

Repeat U&E within 10 – 14 days

Check for ADVERSE EFFECTS


Spironolactone

Eplerenone (heart failure developing post MI)

✝ Where possible, aim to maintain patient on triple

therapy of ACE-I (or ARB), Beta-blocker & MRA

Step 3 – Monitoring

Repeat U&E at 2, 4, 8 & 12 weeks (sooner if indicated) after starting / increasing dose

Thereafter, 3 – 6 monthly U&Es

Consider dose up-titration after 4 – 8 weeks o Repeat U&E schedule as above

ADVERSE EFFECTS:

Serum K > 5.5mmol/l / creatinine >220µmol/l / eGFR <30,

o Consider other factors e.g. UTI o Reduce dose to 12.5mg daily / 25mg

alternate days o Repeat U&Es 5 - 7 days

Serum K > 6.0mmol/l / creatinine >320µmol/l / eGFR <20,

o stop MRA (d/w cardiologist) o Repeat U&E 5 – 7 days

Serum K > 5.5 & clinically overloaded o consider reducing ACE-I / ARB,

where appropriate✝

GI disturbance o Stop if persistent diarrhoea & repeat

U&Es at earliest convenience

Breast enlargement or tenderness o Switch to Eplerenone

D/W Cardiologist



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Mineralocorticoid Receptor Antagonist in HF-REF

MRAs (Spironolactone & Eplerenone) are recommended in all patients with symptomatic chronic heart failure due to HF-REF (NYHA II – IV), unless contra-indicated, to reduce mortality and Heart Failure hospital admission. (ESC 2016)

Which MRA?

Unless treatment commenced following a Myocardial infarction, Spironolactone is first line choice for patients with symptomatic heart failure.

Eplerenone should be considered for patients who develop breast discomfort or gynaecomastia.

Both medications have a starting dose of 25mg daily, with a target dose of 50mg daily. However, a smaller starting dose of 12.5mg daily or 25mg alternate days (whichever best suits the patient) may be considered for elderly or frail patients or those with some renal impairment.

Advice for patients taking a MRA

Explain expected benefits: potential increased survival, improved symptoms and prevention of worsening heart failure.

Explain that symptom improvement may occur within a few weeks to a few months of starting treatment.

Provide patient information leaflet, contact details and symptom advice sheet.

Advise patient to take medication with food.

Inform patient to keep the GP / HFN informed of unwanted side effects such as stomach upsets, headaches, breast discomfort & breast lumps.

Advise patient to temporarily stop Spironolactone if diarrhoea / vomiting occur or infection / fever leading to increased perspiration and contact GP / Nurse.

Inform patient to avoid NSAIDs purchased over the counter and ‘lo-salt’ preparations



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Algorithm for the use of Sacubitril/Valsartan - Angiotensin Receptor Neprilysin Inhibitor (ARNI)

Confirmed HF-REF

EF < 35%

Suitable for initiation of Sacubitril / Valsartan?

Review medical history and identify if any current contra-indications

Step 1 – Assess whether suitable for treatment

Stable NYHA class II – IV on optimum dose of ACE-I or ARB

BP ≥ 100mmHg

eGFR ≥ 30ml/min/1.73m2

Serum K < 5.4mmol/l

Discuss patient with cardiologist to confirm suitability. Arrange an appointment / Echo as directed.

Step 2 – Initiation of Sacubitril / Valsartan

See dosing schedule for starting dose

Consider starting lower dose: o SBP 100 – 110mmHg o eGFR 30 – 60 o Low ACE-I / ARB dose (see table)

Inform patient of benefits & risks

If taking ACE-I, advise 48 hours washout period of ACE-I before starting Sacubitril / Valsartan

If taking ARB, advise start Sacubitril / Valsartan the following day after stopping ARB

Advise patient to report adverse effects to team


Formulary position to be initiated on advice of specialist team

Consultant cardiologist will provide prescription

Step 3 – Review & dose increment

Review clinical status in 1 week

Monitor renal function 1 – 2 weeks

Check for & manage adverse effects**

Clinic review 2 – 6 weeks

Titrate according to dosing schedule aiming for maximum tolerated dose

Repeat step 3

Contra-indications:

SBP < 100mmHg eGFR 30ml/min/1.73m

2

Serum > 5.4mmol/l Previous history of angioedema Severe hepatic impairment Concomitant use with ACE-I or ARB Concomitant use with Aliskiren containing products in patients with diabetes or eGFR <60ml/min/1.73m2 2nd & 3rd trimester pregnancy

Caution:

Hepatic impairment eGFR 30 – 60ml/min/1.73m2 – consider starting lower dose SBP 100 – 110mmHg – consider starting lower dose

**ADVERSE EFFECTS

Symptomatic hypotension

Consider reducing other BP lowering medication

Correct volume depletion / consider adjusting diuretic dose

Consider reducing or discontinuing Sacubitril / Valsartan dose

Hyperkalaemia


Renal dysfunction

Correct volume depletion / consider adjusting diuretic dose


Angioedema

Immediately stop Sacubitril / Valsartan



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Sacubitril / Valsartan in Chronic Heart Failure due to HF-REF

Sacubitril / Valsartan is an Angiotensin Receptor Neprilysin Inhibitor (ARNI), including both the neprilysin inhibitor (Sacubitril) and an angiotensin II receptor blocker (Valsartan).

It is licensed for use in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction. NICE TA516 states that Sacubitril / Valsartan is recommended as an option for treating symptomatic chronic heart failure with reduced ejection fraction, only in people:

with New York Heart Association (NYHA) class II to IV symptoms and

with a left ventricular ejection fraction of 35% or less and

who are already taking a stable dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor-blockers (ARBs).

Prior treatment with an ACE inhibitor or ARB is a pre-requisite in accordance with NICE TA388. However, treatment must be stopped prior to initiation of sacubitril valsartan (see dosing schedule).

Treatment with Sacubitril / Valsartan should be started by a heart failure specialist with access to a multidisciplinary heart failure team. Dose titration and monitoring should be performed by the most appropriate team member as defined in NICE’s guideline on chronic heart failure in adults: management.

Locally it is expected that initiation will be done under the direct supervision of a consultant cardiologist & heart failure nurse specialist team. Once stabilised on treatment, the responsibility for continued prescription of Sacubitril / Valsartan would pass to the patient’s GP.

Sacubitril / Valsartan will be prescribed using its generic name, to avoid accidental prescribing of concomitant ACE-I or ARB.

ACE-I / ARB doses equivalent to daily dose of Enalapril 10mg (used in PARADIGM study) McMurray 2016

ACE Inhibitor Angiotensin II Receptor Antagonist

Ramipril 5mg Candesartan 16mg

Lisinopril 10mg Losartan 50mg

Perindopril 4mg Valsartan 160mg

Patients who are taking less than the equivalent dose of Enalapril 10mg, which was used as the starting dose in the PARADIGM trial, will follow the low dose ACE-I / ARB arm of the dosing schedule.

Patients taking an equivalent or higher dose will follow the target ACE-I / ARB arm of the dosing schedule, unless SBP or eGFR indicate a low dose is initiated.



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Dosing schedules – Sacubitril / Valsartan

Schedule for Patients stable on an ACE-I

Schedule for Patients stable on an ARB

Advice for Patients taking Sacubitril / Valsartan

Explain expected benefits: o Sacubitril/Valsartan was compared to Enalapril (an ACE inhibitor) in a large clinical trial,

the results of which showed an improvement for heart failure patients. o For those patients tolerating an ACE-I / ARB, changing this medication to Sacubitril /

Valsartan has been shown to improve life expectancy and reduce risk of hospital admission (Paradigm 2014).

Provide clear instructions on when to stop ACE-I / ARB and when to start new treatment including advice about washout period.

Advise to report any unwanted / adverse effects to team incl. light-headedness Patient advised to stop Sacubitril / Valsartan immediately and seek urgent review if tongue /

throat swelling occurs. Stress importance of regular U & Es following initiation and titration to monitor renal function Provide information leaflet, including heart failure nurse contact details and symptom

information and ask patient to report any changes in symptoms.

STOPACE-I

CONTINUATION DOSE FOR 3 – 4 WEEKS

49mg/51mg twice daily

INITIATION DOSE FOR

3 – 4 WEEKS


INITIATION DOSE FOR 3 – 4 WEEKS


48 HR WASHOUT

PERIOD

STOP ARB

RECOMMENDED DOSE (AS TOLERATED)


INITIATION DOSE FOR 3 – 4 WEEKS




INITIATION DOSE FOR

2 – 4 WEEKS


CONTINUATION DOSE FOR 3 – 4 WEEKS






Low dose ACE-I / ARB

BP 100 - 110mmHg

eGFR 30 – 60

Low dose ACE-I / ARB

BP 100 - 110mmHg

eGFR < 30 - 60

Target ACE-I / ARB

BP > 110mmHg

eGFR >

Target ACE-I / ARB

BP > 110mmHg

eGFR > 60



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Algorithm for the use of Ivabradine in Heart failure & Sinus Rhythm

Confirmed HF-REF

Ejection Fraction < 35%

Contra-indications:

Unstable cardiovascular conditions (ACS, stroke/TIA, severe hypotension)

Severe Liver or renal dysfunction (eGFR < 15ml/min/1.73m2)

2nd & 3rd degree heart block

Cautions:

Severe (NYHA class IV) heart failure

Exacerbation of heart failure within past 4 weeks

Moderate liver dysfunction

Chronic retinal diseases

Drug interactions: o Potential risk of bradycardia and inducement of

long QT Verapamil, diltiazem (should be discontinued) Beta-blocker Digoxin Amiodarone

o Strong inhibitors of isoenzyme CYP3A4 cytochrome P450) Antifungal azoles (i.e. ketoconazole,

itraconazole) Macrolide antibiotics (i.e. clarithromycin,

erythromycin) HIV protease inhibitors (neflinavir, ritonavir) Grapefruit Juice St John’s wort

Step 1 – assess whether suitable

Stable NYHA class II – IV symptomatic heart failure

Treated with maximally tolerated evidence based doses of ACE-I / ARB, BB and an MRA

ECG confirms sinus rhythm

HR >75bpm

Cardiologist agreement obtained

Step 2 – Initiation of Ivabradine

Educate patients re: purpose, benefits, potential adverse effects** and symptom monitoring

Stop calcium channel blocker (verapamil, diltiazem). Allow 1 day before commencing Ivabradine.

Usual starting dose 5mg twice daily

Consider starting dose of 2.5mg twice daily in patients over 75 years or patients with frailty


Formulary position to be initiated on advice of specialist team

Suitable for initiation of Ivabradine?

Review medical history and identify and current contra-indications

Step 3 – review and dose increment

Review clinical status 1 - 2 weeks

Check for and manage adverse effects

Clinic assessment 6 weeks o Obtain ECG to confirm SR & / or rule out

heart block o Adjust Ivabradine according to dosing

schedule o Aim for target or maximum tolerated

dose

IF ADVERSE EFFECTS SEE BOX**

**ADVERSE EFFECTS

Atrial Fibrillation (stop treatment as ineffective – d/w cardiologist)

Bradycardia, dizziness, syncope (reduce / stop treatment if HR < 50bpm, obtain ECG)

1st

degree heart block (d/w cardiologist)

Luminous phosphenes (usually improves within a few months)

Blurred vision

Headaches

GI (diarrhoea, constipation, nausea)

Refer to BNF for full list of potential adverse effects



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Ivabradine in Chronic Heart Failure due to HR-REF

Ivabradine is a pure heart rate lowering agent, acting by selective and specific inhibition of the cardiac pacemaker If current, which controls the spontaneous diastolic depolarisation in the sinus node and regulates heart rate.

An elevated heart rate (HR) is a significant marker of mortality and morbidity in many cardiovascular diseases including heart failure.

In the SHIfT study (2010), the addition of Ivabradine to evidence based treatment of ACE-I, BB, and MRA, in patients with chronic heart failure and an ejection fraction (EF) < 35%, who were in sinus rhythm with a HR > 70bpm, led to a combined reduction in the risk of cardiovascular death and heart failure hospitalisation.

A retrospective subgroup analysis revealed a survival benefit in those patients with a reduced EF, in sinus rhythm with a HR >75bpm and subsequently, Ivabradine has been licensed accordingly.

Advice for patients

Explain expected benefits of Ivabradine: to prevent worsening heart failure leading to hospital admission and increase survival

To help detect potential bradycardia, teach patients how to measure their pulse and encourage them to monitor and record his / her pulse routinely

Inform patient to avoid grapefruit juice since it increases plasma concentration of Ivabradine increasing risk of adverse effect

Inform patient of and advise them to report potential side effects due to bradycardia: breathlessness, fatigue, syncope & dizziness and other side effects such as luminous visual phenomena

Dosing schedule & problem solving

<75 years >75years

Starting dose (HR>75bpm) 5mg twice daily 2.5mg twice daily

HR>60bpm 7.5mg twice daily 5mg twice daily

HR>60bpm 7.5mg twice daily

Start with a low dose and titrate no more frequently than at 2 week intervals (see table)

Aim for target dose or highest tolerated dose based on resting heart rate. If resting heart rate between 50 – 60bpm, current dose should be maintained. If resting heart rate < 50bpm or symptoms of bradycardia, reduce or stop

Ivabradine Consider need for other rate limiting medications or those that interfere with

liver metabolism Arrange ECG to exclude other bradycardia rhythm disturbances Consider screening for other causes of bradyarrhythmia e.g. thyroid disease



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If patient develops persistent atrial fibrillation, Ivabradine should be discontinued

Visual phenomena usually improve during the first few months of treatment. However, if they result in patient discomfort, Ivabradine should be stopped.

Algorithm for the initiation of diuretic therapy

Assess patients’ fluid/sodium intake

Record weight

Address non-pharmacological and lifestyle issues If possible discontinue aggravating drugs e.g.

NSAIDS, most calcium channel blockers

Confirm the diagnosis of HF-REF

Add Angiotensin Converting Enzyme Inhibitor (NYHA class I-IV)

1st Choice - Furosemide

Consider modest dose 20 -40mg

Increase dose of loop (see titration algorithm and/or

Consider Spironolactone

Persisting signs of sodium and water retention?

Then add Beta Blocker (NYHA I-III)

Continue existing therapy

Monitor changes in fluid retention/depletion:

Daily weights (rising & falling)

Blood pressure (postural hypotension) Signs of oedema e.g. ankle, JVP & breathlessness

etc.

Blood chemistry (U&E’s)

Rising urea = dehydration

Are there persisting sodium and water retention?

NO YES

Baseline U&E on referral*Documentation of dry weight

*Alert Levels: (Before starting treatment)

Urea > 15 mmol/L

Creatinine > 200mol/L

Sodium < 130 mmol/L

Potassium <3.5mmol/L >5.5mmol/L

or 30% rise in Creatinine or urea

from the baseline

Assessment of patient for signs of sodium and water retention: Pitting oedema e.g. ankle, leg and sacral area etc

Pulmonary oedema e.g. chest x-ray or Crackles

Raised JVP (jugular venous pressure) Sudden weight gain (more than 1-2 kg in less than 3 days)

Are there any of the above?

Cautions:

Pregnancy / breast feeding

Hypotension

Liver failure

Prostatic enlargement Porphyria

YES NO

NO YES

ADVERSE EFFECTS / SIGNS OF DEHYDRATION:

Dizziness

Constipation

Weight loss >1kg/day

Reduced skin turgor Disproportionate rise in urea

Fatigue

Thirst

Oliguria



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Algorithm for Diuretic Titration

Monitor changes in sodium & water retention

Consider Trouble-shooting strategies✝

Signs of fluid retention? Signs of fluid depletion?

Increase in weight >1 – 2kg in 3 days

Increasing peripheral oedema

Increase breathlessness

Raised JVP

Chest crackles

Decrease in weight (below dry weight)

Postural hypotension

Reduce skin turgor

Raised blood urea (see Alert level)

See clinical signs of dehydration

Aim to maintain dry weight on minimal diuretic dose required

Monitor U&Es

Patient self-management Education*:

Daily weight monitoring

Signs & symptoms monitoring

Blood testing

Medication information

When to seek advice

Incremental reduction of diuretic dose (see doing schedule)

Patient education*

Incremental increase of loop diuretic dose allowing at least 3 days between each adjustment (see dosing schedule)

Patient education*

Repeat U&Es within 7 – 14 days

Review within 2 weeks to reassess

Signs & Symptoms still present?

Signs & Symptoms still present?

Signs & Symptoms resolved?

Other considerations: Consider merits of adding MRA in place of incremental loop diuretic

adjustment (NYHA II – IV). See MRA Algorithm.

Presence of food in the gut can reduce Furosemide bioavailability and patients should be advised to take Furosemide before food.

Bumetanide has a greater bioavailability and could be substituted if furosemide not effective or not tolerated (see dosing schedule).

Thiazide / Thiazide like diuretic may be used in combination with loop diuretics as it may have a synergistic effect and can help to control fluid retention that has proven resistant to increased doses of loop diuretic and Spironolactone (see combination diuretic algorithm).



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✝Trouble-shooting: Hypotension:

Asymptomatic o Consider reducing dose if no signs of fluid congestion

Symptomatic: o Reduce diuretic if no signs of fluid congestion o Review need for nitrates, calcium channel blockers and other vasodilators. Reduce dose where suitable. o N.B. fluid congestion may cause low blood pressure, which may recover as fluid is offloaded. May need to

consider temporary reduction of ACE-I / BB. o Discuss with cardiologist if above does not resolve problem

Hypokalaemia / Hypomagnesaemia:

Consider increasing ACE-I/ARB

Consider adding MRA, K+ supplements, Mg++ supplements Hyponatraemia:

Volume depleted: o Reduce / stop dose of loop / thiazide diuretic

Volume overload: o Consider fluid restriction o Increase dose of loop diuretic & continue to monitor electrolytes carefully o Discuss with cardiologist if above does not resolve problem

Hyperuricaemia / gout

Consider allopurinol prophylaxis

For acute gout consider Colchicine

Avoid NSAIDS Hypovolaemia / dehydration

Assess volume status & consider reduction of diuretic dose Insufficient diuretic response

Check adherence and fluid intake

Loop on an empty stomach

Increase dose of diuretic

Consider switching furosemide to Bumetanide

Add MRA / increase MRA dose

Combine loop / thiazide

Consider hospital admission for IV diuretic Renal impairment (rising urea / creatinine)

Check for hypovolaemia / dehydration

Exclude use of nephrotoxic agents e.g.NSAID

Consider reducing ACE-I/ARB

Withhold MRA

If using combined loop / thiazide diuretic, stop thiazide

Consider hospital admission Compliance:

In certain circumstances a patient may prefer to take their diuretics as a once only dose – this may be acceptable if compliance is improved.

Taken from ESC guidelines (2016) – practical guidance on the use of diuretics in patients with heart failure



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Diuretic Management in patients with chronic heart failure

Potentially, all patients with chronic heart failure and, symptoms & signs of fluid congestion, will require diuretics to relieve breathlessness and oedema.

Diuretics should be used in combination with an ACE-I, Beta-blocker and MRA (unless these are not tolerated / contra-indicated) until signs of congestion have been relieved.

Patients should be started on a low dose (see doing schedule), that is effective to achieve diuresis and a weight loss of 1 – 2lb / day (0.75 – 1kg).

Diuretic dose should be adjusted according to symptoms & signs of congestion, blood pressure and renal function, using a minimum dose to maintain euvolaemia / patients dry weight.

Dosing Schedule – Furosemide Dosing Schedule - Bumetanide

Advice for patients taking diuretics

Explain expected benefits: to improve symptoms and exercise capacity.

Use patient information leaflet, contact details and symptom sheet.

Advise patient to take tablets as prescribed, however timing may be altered according to the their daily routine, explaining that the diuretic effects will occur within one hour and last for approximately six hours.

Advise patients to weigh themselves daily, reporting weight loss / gain more than 1 kg / day on 2 consecutive days - aiming to achieve their approximate dry weight (if known).

Advise patient to report signs and / or symptoms of fluid congestion i.e. worsening breathlessness, leg swelling, productive cough etc. to HFNS / GP

Advise patient to report signs and / or symptoms of dehydration / over-diuresis

Advise patient to ensure an adequate daily fluid intake; generally 1 ½ - 2 litres (6 – 8 mugs), but to consider an extra 1 – 2 mugs daily to replace insensible fluid loss during hot weather / fever

Advise patient to report diarrhoea and / or vomiting to HFNS /GP

Step Morning Midday

1 1mg

2 1mg 1mg

3 2mg 1mg

4 2mg 2mg

5 3mg 2mg

Step Morning Midday

1 40 mg

2 40mg 40mg

3 80mg 40mg

4 80mg 80mg

Additional clinical signs and symptoms of electrolyte imbalance / dehydration:

Weakness, lethargy, drowsiness

Collapse, restlessness

Muscle pains / cramps, muscle fatigue

Hypotension

Tachycardia

Gastrointestinal disturbances such as nausea, vomiting

Incontinence

Gout can also be considered a sign



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Algorithm for the use of Combination Diuretic Therapy

Persistent signs of oedema despite high dose loop diuretic

Discuss with cardiologist

Worsening signs of congestion despite combined therapy

Deteriorating renal function hindering treatment

Thiazide contraindicated:

Weight loss ≤ 3kg in 24 hours

SBP < 90mmHg

Serum K < 3.5mmol/l

Serum Na < 125mmol/l

Patient unwilling or unable to self-medicate Renal failure with anuria

Step 2 – Consider regime & Monitoring

Prior to adding a thiazide, consideration should be given to switching to another loop, namely Bumetanide, as this can often improve GI absorption

Which thiazide? Refer to baseline U&Es*

Patients should be encouraged to take a low sodium diet (<2g) and aim for a moderate daily fluid intake of 1.5 – 2 litres.

Educate patient to correctly monitor weight and where possible check signs of oedema

Start with 2.5mg daily as a once only dose

Telephone / face to face assessment of patient’s symptomatic response, weight and signs of congestion, where possible the following day (avoid starting combination diuretic on a Friday)

U&Es should be monitored at least weekly

Consider trouble shooting strategies✝

Dose may be repeated after 24 – 48 hrs if positive clinical response, but signs of congestion persist

Consider diuresis with a regime of 2.5mg 2 – 3 x weekly until dry weight achieved

Some patients require daily dose of 2.5mg – 5mg daily, which may be acceptable if renal function stable

Once desired effect achieved, the dose should be reduced and the patients maintained on the lowest possible dose to control their symptoms.

Dosage adjustment will be based on both clinical and laboratory evaluation

Step 1 – Assess whether patient suitable:

Patient not responding to a loop diuretic who presents with one or more of the following:

Increased dyspnoea

Weight gain ≥ 2kg

Evidence of peripheral oedema / abdominal distension

Basal crepitations

Elevated JVP

Gallop rhythm / pulsus alternans

*Baseline U&Es:

eGFR > 30ml/min consider Bendroflumethiazide 2.5mg

eGFR < 30ml/min consider Metolazone 2.5mg



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Combination therapy with Loop & Thiazide Diuretic

In severe heart failure (NYHA III – IV), thiazides may be used in combination with a loop diuretic as it may have a synergistic effect. In this context, Bendroflumethiazide or Metolazone are powerful diuretics that can be used to treat resistant oedema (ESC 2016).

Bendroflumethiazide is a thiazide diuretic, which inhibits the renal tubular absorption of salt and water in the distal convoluted tubule. It is effective in generating diuresis in patients with an eGFR > 30ml/min/1.73m2 . Metolazone is a thiazide type diuretic, which unlike other thiazides retains its effectiveness at eGFR < 30ml/min/1.73m2 . Typically, once the patient is rendered euvolaemic, it can be dosed as infrequently as two to three times a week because of its very long half-life. If fluid retention persists despite addressing the above measures, U&Es should continue to be monitored and liaison sought with Cardiologist / GP / palliative care services to consider additional treatment options. Dose adjustment

Metolazone and Bendroflumethiazide are long acting diuretics and should

preferably be taken in the morning, although some patients may tolerate it more comfortably if their diuretics are staggered. Conversely, patient concordance may be improved by keeping the regime as simple as possible and it is important to involve the patient / carer when formulating plan.

Close monitoring of renal function during combination therapy is required during the first four weeks of treatment. If renal function remains stable and combination therapy is to continue, renal function may be tested monthly and / or alongside any other medication change.

Metolazone and Bendroflumethiazide should be initiated very cautiously and symptoms controlled using the lowest possible dose. They should be discontinued if diarrhoea or signs of dehydration occur.

When the initial desired therapeutic effect has been obtained, the thiazide dose should be reduced to a lower maintenance level (e.g. 2.5 mg once / twice weekly). Dosage adjustment is usually necessary during the course of therapy, depending upon the severity of patients’ clinical condition.

Monitoring Following commencement of Bendroflumethiazide or Metolazone:

Patients should receive contact from the HFN the following day, via telephone or in person and be reviewed at least weekly thereafter; monitoring for changes in U&Es / signs and symptoms of fluid retention

If profuse diuresis occurs, patients should receive lying & standing BP measurement (since this can lead to orthostatic hypotension).

Hypokalaemia may occur and is particularly hazardous in the presence of Digoxin. Consider dose adjustment or if serum potassium falls below 3.5mmol / litre, consider potassium replacement.



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If the dose is altered, the patient should be advised to contact the HFN if symptoms change and telephone contact / clinic / home visit arranged within 3 – 5 days to monitor symptoms and repeat / review U&Es.

Advice for patients taking combination diuretic therapy

Explain expected benefits: to improve symptoms and mobility. Provide information leaflet, including heart failure nurse contact details and

symptom information and ask patient to report any changes in symptoms. Advise patient to weigh themselves daily and report weight loss / gain greater than

1kg (2lb) per day, aiming to achieve their approximate dry weight (if known) Advise patient to report symptoms of light-headedness / dizziness as this may

indicate over treatment Inform patient to report episode of diarrhoea or vomiting

When treating worsening signs of fluid retention, the patient should be assessed for underlying causes of decompensation and advice sought from Consultant / GP to treat these as appropriate.

Possible causes include:

Non-cardiac

Non-compliance with general advice e.g. salt intake, fluid intake, medications Recently co-prescribed medications e.g. NSAIDs, anti-arrhythmic Concurrent infection Alcohol use Anaemia Renal dysfunction Pulmonary embolism ‘Over the counter’ medicines incl. St John’s Wort Thyroid dysfunction

Cardiac Atrial Fibrillation Supraventricular / Ventricular arrhythmias Bradycardia Excessive preload reduction (diuretics & ACE-I) Myocardial Ischaemia Valve disease Uncontrolled hypertension

If patient is not responding to diuretic regime, review diagnosis, consider other non-cardiac causes of worsening symptoms and liaise with Consultant / GP.

If managing decompensation, the HFN should review CRT criteria and consider arranging an up to date ECG and if required Echocardiogram to assess whether patient might be suitable for a CRT device (see CRT guidance)



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Algorithm for the use of Digoxin in Heart failure

Confirmed HF-REF

Indications:

Atrial Fibrillation (HR ≥ 90bpm)

Decompensated Heart Failure (NYHA class III – IV) – d/w cardiologist

Contra-indications:

See BNF for full list of interactions

Clinical instability

Known allergy to digoxin

Severe renal impairment (creatinine >200mmol/l, eGFR <30ml/min/1.73m2)

2nd & 3rd degree heart block

Hypokalaemia (K less than 3.5mmol/l).

Hypotension – Systolic BP less than 90mmHg. Wolff-Parkinson-White syndrome.

Recent myocardial infarction

Cautions: Risk of digoxin toxicity

o Hypercalcaemia o Hypokalaemia (correct before initiating digoxin) o Hypomagnesaemia

Thyroid disease

Sick sinus syndrome Severe respiratory disease

Interactions: Amiodarone, Propafenone, and Quinine (may affect renal clearance

leading to increased plasma levels of digoxin)

Erythromycin, Omeprazole and Tetracycline (increases digoxin absorption & subsequent plasma levels)

Antacids, Colestipol, Cholestyramine (decreases digoxin absorption) Interaction can be prevented by separating doses of medications by 2 hours.

Increased risk of digoxin toxicity in: hypokalaemia, hypomagnesaemia, hypercalcaemia and hypothyroidism

Digoxin combined with beta-blockers and / or calcium channel-blockers may lead to enhanced AV nodal blockade and bradycardia.

This list is not exhaustive; please refer to BNF and Summary of Product Characteristics for further information

Step 1 – assess whether suitable

Treated with maximally tolerated evidence based doses of ACE-I / ARB, BB and an MRA

Obtain ECG (see Contra-indications) Monitor U&Es & LFTs

o eGFR > 30ml/min/1.73m2 o Serum K+, Mg++ & Ca++ within normal

range Patient receiving other anti-arrhythmic

medication (d/w cardiologist) Consider suitability for Cardiac Resynchronisation Therapy (CRT) -see CRT guidance

Step 2 – Initiation of Digoxin

Educate patients re: purpose, benefits, potential adverse effects and symptom monitoring

Initial dose 62.5mcg – 125mcg daily

Use lower dose in elderly, weight <50kg or eGFR 30 – 60ml/min/1.73m2


Suitable for initiation of Digoxin?

Review medical history and identify and current contra-indications

Step 3 – review and dose increment

Review clinical status 1 - 2 weeks

Check for and manage adverse effects Clinic assessment 6 weeks

o If symptoms persist and / or AF with HR> 90bpm consider increasing dose

o Incremental increase of no more than 62.5mcg

o Maximum dose 125mcg (250mcg if weight > 70kg and eGFR >90ml/min/1.73m2)

IF ADVERSE EFFECTS SEE BOX**

**ADVERSE EFFECTS Common side effects include nausea and anorexia and may occur with normal plasma levels Toxicity symptoms may include nausea & vomiting, diarrhoea, abdominal pain, visual disturbance, headaches & confusion. If symptoms occur consider:

Reducing or discontinuing Digoxin

SBP < 90mmHg consider reducing / discontinuing Digoxin

HR < 55bpm consider reducing / discontinuing Digoxin Review medications for possible interactions

Obtain ECG - changes suggesting toxicity stop Digoxin (d/w cardiologist)



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Digoxin in Chronic Heart Failure due to LVSD

In patients with symptomatic heart failure and atrial fibrillation, Digoxin may be useful to slow a rapid ventricular rate, when other therapeutic options are not suitable e.g. beta-blockade. Optimal resting ventricular rate for patients with heart failure and atrial fibrillation is not established, but a range between 70 – 90 is considered acceptable. ESC (2016)

Digoxin may also be considered for patients in sinus rhythm with worsening heart failure due to left ventricular systolic dysfunction, despite treatment with evidence based doses of ACE-I / ARB, BB and an MRA, in an attempt to reduce heart failure symptoms and risk of hospitalization. In this situation, the HFN should discuss merits of adding Digoxin with consultant cardiologist, before commencing treatment.

Dose adjustment

Digoxin has a narrow therapeutic index so there is a high risk of toxicity. The usual daily dose of oral Digoxin is 125 – 250 micrograms if the serum

creatinine is within normal range / eGFR >60ml/min/1.73m2. (higher doses are rarely used for heart failure)

U&Es should be obtained prior to commencement of digoxin paying particular attention to renal function and serum K+ and hypokalaemia corrected.

When dosing, consider patient’s ideal bodyweight and creatinine clearance Digoxin 125 micrograms is the usual initial dose Digoxin 62.5micrograms daily should be considered for patients under 50kg,

with moderate renal impairment (eGFR 30 – 60ml/min/1.73m2)or whose age is greater than 70 years

Digoxin 250 micrograms daily may be considered for patients over 70kg (non obese weight) with no renal impairment.

If symptoms remain and AF heart rate ≥ 90, consider increasing the dose (if appropriate).

Dose should be increased in increments of 62.5micrograms at not less than 2 weekly intervals.

Advice to patient / carer

Explain expected benefits: treatment given to control symptoms and reduce

hospital readmission due to worsening heart failure Provide patient information leaflet with contact details and symptom advice

sheet Provide advice on potential side effects to report to GP / heart failure nurse,

including: nausea, vomiting, diarrhoea, abdominal pain, visual disturbances, headaches, tiredness, drowsiness



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Cardiac resynchronisation Therapy (CRT-P / CRT-D)

Pharmacological treatment of heart failure aims to improve life expectancy and quality of life and remains the gold standard for heart failure management. However, as the condition becomes more severe, cardiac function and symptoms may no longer be controlled by this treatment alone. Myocardial cell death and fibrosis can lead to damage of the conduction system, which in turn results in a much slower depolarisation process. The resulting broadening of the QRS, typically Left bundle branch block (LBBB), can cause ventricular dyssynchrony (parts of ventricle contracting at different rate and force to other parts) and subsequent impaired stroke volume and cardiac output. Pacing both right and left ventricles simultaneously can help to improve overall cardiac performance. Implantable pacemaker devices known as cardiac resynchronisation therapy pacing (CRT-P) devices or cardiac resynchronisation therapy defibrillator (CRT-D) devices may help to improve heart failure symptoms and reduce mortality and morbidity. ESC (2016) The following treatment options with ICD or CRT for people with heart failure, who have left ventricular dysfunction with an LVEF of 35% or less, is taken from NICE technology appraisal guidance 314 (2014).

All patients referred by cardiology will have previously been assessed for ICD / CRT suitability, and those deemed suitable referred to local implantation centre. However, heart failure is a long term condition and since both cardiac function and functional ability may decline, the patient’s suitability may change. Consequently, consideration to the above guidance should be made during routine clinic review, and in particular where the patient’s heart failure is decompensating. An ECG will be obtained, to assess QRS duration and morphology, and if it is believed the above criteria is met; the patient will be discussed with a cardiologist, who will advise whether up to date echocardiogram and / or consultant review required.



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Advice to patient

Explain reason suitability for cardiac device considered.

Inform patient the bottom chambers of the heart may be beating out of synchrony and not contracting efficiently.

Advise where this is confirmed, an implantable pacemaker called bi-ventricular device or Cardiac resynchronisation can be fitted to correct this.

Inform patient that occasionally, there can be problems with the electrical system that can lead to the heart misfiring.

Advise where there is a risk of the heart misfiring, their consultant may recommend the device also has a function called cardiac defibrillation.

Explain expected benefits:

To help the heart pump more efficiently

To help reduce symptoms of breathlessness and fatigue

To help improve functional ability (approx. 60% experience symptomatic improvement)

To help them live for longer

Explain the consultant will inform them of benefits / risks in more detail.

Give the patient opportunity to ask and answer any questions.

Offer copy of BHF and / or Pumping marvellous Cardiac Device booklets



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Algorithm for Management of Hypokalaemia

Definition

Mild hypokalaemia 3.1 – 3.5 mmol/l

Moderate hypokalaemia 2.6 – 3.0 mmol/l

Severe hypokalaemia ≤2.5mmol/l

Correct likely causes:

Consider reducing loop / thiazide diuretic if clinically indicated

Consider adding / increasing dose of ACE-I / ARB

Consider adding / increasing dose of MRA if clinically indicated

Advise patient to increase intake of K rich foods

Check & correct low serum Magnesium levels (refer to GP / Consultant)

Refer to GP / Consultant:

Severe hypokalaemia –seek urgent advice

Severe renal dysfunction eGFR < 30ml/min/1.73m2

Hypomagnesaemia

Diarrhoea and / or vomiting

Excessive loss from ileostomy

Marked clinical features of hypokalaemia: o ECG changes o Lethargy, confusion o Muscle weakness o Paraesthesia o Nocturia or polyuria

Replacement:


Potassium Bicarbonate and Chloride Effervescent tablets (Sando K)

Kay Cee L

Mild hypokalaemia Sando K 2 tablets 1 –3 times a day until K > 3.5mmol/l (Equivalent to 24 – 72mmol K) *Kay Cee L 25ml 1 – 3 x daily (25 – 75mmol k) Moderate hypokalaemia Sando K 2 - 3 tablets 2 – 3 times a day until K > 3.5mmol/l (Equivalent to 48 - 108mmol K) *Kay Cee L 25ml 2 - 4 x daily (50 – 100mmol) When considering most appropriate dose, take into account severity of serum K decline and whether there is continuing potassium loss.

Adverse effects:

GI disturbance o Advise patient to take with food and

dissolve fully in water. o Consider Kay Cee L if patient

experiencing symptoms of gastric irritation*

Hyperkalaemia o Monitor U&Es closely (at least weekly

until serum K stabilised)

Monitoring:

If available, perform ECG

Telephone review within 1 week

Repeat U&E in 3 days with regular serum K monitoring (1 – 2 x weekly) until stabilised

Persistent hypokalaemia – consider increasing supplement within above parameters

o Reassess risk status and seek advice if indicated

Once stable and / or K+ ≥4.5mmol/l, reassess need for supplementation.

Assess clinical features and risk status - seek advice if indicated



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Potassium replacement

Potassium depletion is commonly seen in patients with chronic heart failure, in which several physiological abnormalities predispose the patient to the development of electrolyte abnormalities.

Management with loop and thiazide diuretics can lead to further potassium depletion.

The major risk is arrhythmia and for patients taking digoxin or anti-arrhythmic drugs, who have heart failure, ischaemia or left ventricular dysfunction, potassium depletion can have serious consequences.

Strategies to minimise potassium loss include minimising dosage of loop and / or thiazide diuretic and for patients who appear euvolaemic, reduction of these should be considered.

Treatment of hypokalaemia requires careful attention to treat underlying cause. When the cause is diuretic therapy, which must be continued, a variety of measures including dietary modification, mineralocorticoid antagonists and potassium supplements may be considered.

For those patients with very mild hypokalaemia, increasing dietary potassium intake alone may be sufficient to restore serum potassium levels to normal, but continued biochemistry monitoring is required until serum potassium has stabilised.

Potassium supplements can cause nausea and vomiting and poor compliance can be a major limitation to their effectiveness; suitability for / increasing dose of mineralocorticoid receptor antagonists (MRAs) or ACE-I / ARB should be reviewed prior to considering K supplementation.

Patients with moderate – severe hypomagnesaemia typically have hypokalaemia, which until magnesium level is corrected, respond poorly to treatment. Serum magnesium level should be requested and treatment of hypomagnesaemia discussed with GP / consultant.

Potassium Bicarbonate and Chloride Effervescent tablet (Sando K) is considered first line treatment for mild to moderate hypokalaemia. When patients are unable to tolerate Sando K, Kay Cee L may be considered.

The Algorithm dosing range for Sando K / Kay Cee L has been left intentionally broad to allow dosing to be adjusted taking into account factors that might influence continued potassium depletion (e.g. combined loop / thiazide diuretic regime) and severity of depletion (rapid changes are more likely to be significant that slower changes). The algorithm is intended as a guide only and clinical judgement should be used to determine a suitable regime.

Regular monitoring of serum potassium concentration is essential and should be repeated 3 days after commencement of potassium replacement. The need for continued replacement / adjustment of dose will be reviewed and subsequently, reassessed with 1 – 2 weekly U&E (dependent on the patient’s clinical situation) until serum K has stabilised.



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5. Algorithm for Non-pharmacological management

Diagnosis

Clinical Assessment

Self

Management

Prognosis-explore potential disease progression to include long term condition and symptom control

Discuss Causes

Ensure patient/carer has been offered written information i.e BHF / Cardiomyopathy Association booklets Explain Anatomy & Physiology

Record Height, weight, BMI, BP & HR, respiration rate, Oedema Chest auscultation if competent to do so Identify NYHA Classification

Explain general symptom management including:

Paroxysmal Nocturnal Dyspnoea, Breathlessness, Cough, Sputum, Orthopnoea

Fatigue including energy conservation and advice on pacing activities, exercise and sexual activity.

Nausea

Early recognition of worsening symptoms

When and where to seek help Explain self-management of fluids

Educate on the signs & symptoms or peripheral & central oedema

Advise no more than 1 ½ -2 litres/day, depending on clinical signs & symptoms

Consider increased dose of diuretics

Educate on daily weights including who to contact for advice if rapid consistent weight loss or gain within a week.

Diet- Discuss a balanced nutritional intake and explain rationale for the increased risk of malnutrition and cardiac cachexia

Consider referral for Cardiac/lifestyle rehabilitation. This may include exercise

Provide patient / carer with contact numbers for both in office hours and out of hours

Salt

Educate on reducing salt intake

Caution on the use of “Low Salt” and raise awareness of salt content in processed food.

Advise on 2g sodium per day.

Consider referral to dietician for patients with cachexia / obesity

Alcohol

Educate on reducing alcohol intake

Negotiate intake with individual if appropriate

Smoking – Advise on benefits of stopping

Medication – discuss reasons for medications and explore concordance issues

Advise on avoiding aggravating medication, e.g. NSAIDs and rate increasing calcium channel blockers

Advise on immunisation i.e. flu & pneumococcus

Consider referral to smoking cessation programme

Psychological Needs

Assess for symptoms of depression- as per NICE guidance (2009)

Assess for symptoms of anxiety

Advise on support groups- British Heart Foundation, Cardiomyopathy Association

Carers Needs Encourage carer involvement including joint attendance at appointments Check their understanding of condition & care

Home & social situation

Assess environment and peer support mechanisms.

Following initial assessment, frequency of review of Non pharmacological management is indicated by clinical need. Minimum review in heart function clinic is 6 monthly.

Psychological/ Social Needs

Next Review

If symptoms of depression noted, advise patient to refer self to GP or the local depression & anxiety service

Advise on relaxation techniques

Draw patient’s attention to the contact details in the information booklet

Consider referral to Social Services including OT assessment

Consider benefits advice including attendance allowance, disability badge etc.



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6. Depression & Anxiety

6.1. The presence of depression & anxiety symptoms should be reviewed in all patients with chronic physical health problems (NICE 2009) and screening should be considered for patients who may have depression & / or anxiety using suitable screening tools, namely PHQ-4 & PHQ-9.

6.2. Information on the local depression and anxiety service and support agencies will be given to patients where depression and anxiety is identified. Patients will be encouraged to make a self-referral or a referral can be made directly on their behalf.

6.3. The patients GP will be kept informed and advice sought where pharmacological treatment may be indicated.

7. End of life care

7.1. HFNS will explore potential disease progression and provide honest, yet sensitive answers to any questions raised at first contact and during the patient’s episode of care.

7.2. The palliative needs of patients will be identified, assessed and managed at the earliest opportunity. HFNS will liaise with the patient’s wider health & social care teams, in an effort to meet the patient’s holistic needs, including consultant, GP, social care agencies, district nursing and palliative care teams.

7.3. HFNS will continue to support heart failure management, in line with patient’s wishes and best interests, in an effort to alleviate symptoms.

8. Monitoring Compliance with and the Effectiveness of the Guideline

Standards/ Key Performance Indicators

Key performance indicators comprise:

Patients with HF-REF are managed according to this policy Adherence to Quality Statements 3 & 4 (Chronic Heart Failure in Adults - Feb

2016)

8.1. Process for Implementation and Monitoring Compliance and Effectiveness

The policy will be implemented by the Heart Failure Nurse Specialists, following approval from the Cardiology Operational Group and Drugs and Therapeutics Committee.

8.2. Monitoring of this policy will be the responsibility of the Lead Heart Failure Clinical Nurse Specialist:



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Heart failure nurse activity is recorded daily, including medication adjustment and crisis aversion.

Medication adjustments and crisis aversions are collated monthly and shared at the Cardiology Operational Group

HFNS will undertake a documentation audit and a peer review of prescribing decisions, from a random sample of heart failure notes, once every 3 months.

9. Equality Impact Assessment

10. References

ESC (2016) Guidelines for the diagnosis and treatment of acute and chronic heart failure

ESC (2016) Guidelines for the diagnosis and treatment of acute and chronic heart failure – Web Addenda [online] Available at https://www.escardio.org/static_file/Escardio/Guidelines/ehw128_Addenda.pdf [Accessed 30 January 2017]

McMurray J (June 2016) Perspectives in chronic heart failure – new treatment advances. British Journal of Cardiology,23(suppl 1):S1–S16

McMurray JJ, Packer M, Desai AS et al (2014) PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med; 371:993–1004.

NICE (2010) Chronic heart failure in adults: management (CG108) NICE (2016) Quality Standard 9 - Chronic heart Failure in Adults

Group Positive Impact

Negative Impact

No Impact

Comment

Age

Disability

Gender

Gender Reassignment

Human Rights (rights to privacy, dignity, liberty and non-degrading treatment)

Marriage and civil partnership

Pregnancy n/a

Maternity and Breastfeeding

n/a

Race (ethnic origin)

Religion (or belief)

Sexual Orientation

https://www.escardio.org/static_file/Escardio/Guidelines/ehw128_Addenda.pdf

https://www.escardio.org/static_file/Escardio/Guidelines/ehw128_Addenda.pdf



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Think Kidneys (2016) Changes in Kidney function and serum potassium durinf ACEI/ARB/diuretic treatment in primary care [online] Available at https://www.thinkkidneys.nhs.uk/aki/wp-content/uploads/sites/2/2016/02/Changes-in-kidney-function-during-ACEI-ARB-diuretic.pdf [Accessed 30 January 2017]

NICE (2009) Depression in Adults with a chronic physical health problem: recognition and management. (CG91)

https://www.thinkkidneys.nhs.uk/aki/wp-content/uploads/sites/2/2016/02/Changes-in-kidney-function-during-ACEI-ARB-diuretic.pdf

