SMMART-HF Surgery vs. Medical Treatment Alone for Patients with Significant MitrAl RegurgitaTion & Non-Ischemic Congestive Heart Failure Duke Heart Failure Research Pager:

Purpose  Evaluate the efficacy and safety of SMVR* + OMT** compared to OMT alone in non- ischemic heart failure patients with significant secondary MR***  This is not an experimental study. It compares 2 standard care of practices. *SMVR = surgical mitral valvuloplasty with placement of an annular ring **OMT = optimal medical therapy ***MR = mitral regurgitation

Inclusion Criteria  Symptomatic chronic HF (NYHA class II- IIIb)  Insignificant CAD by angiography  LVEF ≤ 35% and secondary MR on TTE (confirmed on TEE)  Optimal medical therapy for > 6 months  Peak VO 2 ≤ 22 mL/kg/min

Interventions Randomization 1:1 No surgical procedure (OMT only) 60 subjects SMVR + OMT 60 subjects Follow-up: 1, 3, 6, 12, and 18 months.

Nursing Roles  Pre-op education, preparation for OR, and post- op care.  There is no change in care. This is standard pre- op and post-op care.  If an enrolled subject is readmitted to the hospital following the SMVR surgery, please contact research team ( ).

Outcomes Why is this study being done?  Evaluate effect of SMVR + OMT on: LV remodeling LV remodeling Cardiac performance, mortality, morbidity, quality of life, exercise tolerance, and severity of MR Cardiac performance, mortality, morbidity, quality of life, exercise tolerance, and severity of MR Inflammatory & neurohormonal biomarkers, HF symptoms, & remodeling within specific subpopulations of patients Inflammatory & neurohormonal biomarkers, HF symptoms, & remodeling within specific subpopulations of patients  Measured by: Clinical assessment Clinical assessment Minnesota Living with HF questionnaire Minnesota Living with HF questionnaire 6 minute walk test 6 minute walk test Echo Echo Spirometric Cardiopulmonary Exercise Stress Test (CPX) Spirometric Cardiopulmonary Exercise Stress Test (CPX) Blood samples Blood samples