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SMMART-HF

SMMART-HF. S urgery vs. M edical Treatment Alone for Patients with Significant M itr A l R egurgita T ion & Non-Ischemic Congestive H eart F ailure Duke Heart Failure Research Pager: 970-0736. Purpose.

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SMMART-HF

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  1. SMMART-HF Surgery vs. Medical Treatment Alone for Patients with Significant MitrAl RegurgitaTion & Non-Ischemic Congestive Heart Failure Duke Heart Failure Research Pager: 970-0736

  2. 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

  3. 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 VO2 ≤ 22 mL/kg/min

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

  5. 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 (970-0736).

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

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