Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure (SMMART-HF)

• Effect of adding SMVR to OMT alone on LV remodeling, specifically LV end-systolic volume index (LVESVI) [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
  

• Peak VO2 [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
  
• Change in 6-minute walk test [ Time Frame: Measured at baseline and Month 18 ] [ Designated as safety issue: No ]
  
• Change in Minnesota Living with Heart Failure (MLHF) score [ Time Frame: Measured at baseline and Month 18 ] [ Designated as safety issue: No ]
  
• Total days alive and total days not hospitalized [ Time Frame: Measured at baseline and Month 18 ] [ Designated as safety issue: No ]
  
• Total mortality (all causes) [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
  
• Perioperative mortality [ Time Frame: Measured between Days 0 and 30 postsurgery ] [ Designated as safety issue: Yes ]
  

It is estimated that approximately 4 out of 10 people with an enlarged heart due to heart failure develop MR, referred to as secondary MR. This type of MR is caused by enlargement of the left ventricle (LV), one of the heart's main chambers. In turn, the enlargement leads to stretching of certain heart muscles around the mitral valve and of the valve itself. Symptoms of secondary MR may include shortness of breath, fatigue, dizziness, swollen feet, cough, and heart palpitations. Mitral valve repair or replacement surgery is sometimes considered as a treatment option to restore proper heart function in people with secondary MR. Surgical repair with placement of an artificial ring around the mitral valve can help to tighten the valve and add benefit to non-surgical treatments for MR. However, although surgical placement of the ring improves mitral valve function in most people, it is not known whether this surgery helps people live longer and healthier lives. This study will compare the safety and effectiveness of surgical mitral valvuloplasty with placement of an annular ring (SMVR) added to optimal medical treatment (OMT) versus OMT alone in non-ischemic heart failure patients with significant secondary MR.

Participation from baseline through follow-up in this study will last 18 months. All potential participants will initially undergo a transesophageal echocardiogram to confirm the presence of an abnormal mitral valve. Eligible participants will then undergo a number of baseline tests, which will include cardiopulmonary exercise stress testing, a chest wall echocardiogram, blood draw, 6-minute walk test, medical questionnaires, and a physical exam. Next, participants will be randomly assigned to receive immediate open heart surgery with the placement of a mitral valve ring, delayed surgery at least 18 months later, or OMT. Participants assigned to receive immediate surgery will undergo the surgery 2 weeks after baseline testing. Participants assigned to receive OMT will receive treatment with any of the following medication regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy. Follow-up visits for all participants will occur at Months 1, 3, 6, 12, and 18 and will include repeat baseline testing. Long-term survival status data may be collected beyond 18 months for some participants.