SMMART-HFSMMART-HF

SSurgery vs. urgery vs. MMedical Treatment Alone for edical Treatment Alone for Patients with Significant Patients with Significant MMitritrAAl l RRegurgitaegurgitaTTion ion

& Non-Ischemic Congestive & Non-Ischemic Congestive HHeart eart FFailureailure

Duke Heart Failure ResearchDuke Heart Failure ResearchPager: 970-0736Pager: 970-0736

PurposePurpose Evaluate the efficacy and safety of SMVR* Evaluate the efficacy and safety of SMVR*

+ OMT** compared to OMT alone in non-+ OMT** compared to OMT alone in non-ischemic heart failure patients with ischemic heart failure patients with significant secondary MR***significant secondary MR***

This is not an experimental study. It This is not an experimental study. It compares 2 standard care of practices.compares 2 standard care of practices.

*SMVR = surgical mitral valvuloplasty with placement of an annular ring*SMVR = surgical mitral valvuloplasty with placement of an annular ring**OMT = optimal medical therapy **OMT = optimal medical therapy ***MR = mitral regurgitation***MR = mitral regurgitation

Inclusion CriteriaInclusion Criteria

Symptomatic chronic HF (NYHA class II-Symptomatic chronic HF (NYHA class II-IIIb)IIIb)

Insignificant CAD by angiographyInsignificant CAD by angiography LVEF ≤ 35% and secondary MR on TTE LVEF ≤ 35% and secondary MR on TTE

(confirmed on TEE)(confirmed on TEE) Optimal medical therapy for > 6 monthsOptimal medical therapy for > 6 months Peak VOPeak VO22 ≤ 22 mL/kg/min ≤ 22 mL/kg/min

InterventionsInterventions

Randomization 1:1

No surgical procedure(OMT only)

60 subjects

SMVR + OMT60 subjects

Follow-up: 1, 3, 6, 12, and 18 months.

Nursing RolesNursing Roles

Pre-op education, preparation for OR, and post-Pre-op education, preparation for OR, and post-op care.op care.

There is no change in care. This is standard pre-There is no change in care. This is standard pre-op and post-op care.op and post-op care.

If an enrolled subject is readmitted to the If an enrolled subject is readmitted to the hospital following the SMVR surgery, please hospital following the SMVR surgery, please contact research team (970-0736).contact research team (970-0736).

OutcomesOutcomes

Why is this study being done?Why is this study being done?

Evaluate effect of SMVR + OMT on:Evaluate effect of SMVR + OMT on: LV remodeling LV remodeling Cardiac performance, mortality, morbidity, quality of life, exercise Cardiac performance, mortality, morbidity, quality of life, exercise

tolerance, and severity of MRtolerance, and severity of MR Inflammatory & neurohormonal biomarkers, HF symptoms, & Inflammatory & neurohormonal biomarkers, HF symptoms, &

remodeling within specific subpopulations of patientsremodeling within specific subpopulations of patients

Measured by:Measured by: Clinical assessmentClinical assessment Minnesota Living with HF questionnaireMinnesota Living with HF questionnaire 6 minute walk test6 minute walk test EchoEcho Spirometric Cardiopulmonary Exercise Stress Test (CPX)Spirometric Cardiopulmonary Exercise Stress Test (CPX) Blood samplesBlood samples