Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure
Condition: Mitral Valve Insufficiency; Heart Failure
MeSH terms: Heart Failure; Mitral Valve Insufficiency
Intervention: Surgical mitral valvuloplasty with placement of annular ring (SMVR); Optimal medical therapy (OMT)
Intervention description: Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. The ring size will be between 24 mm and 27 mm in the anteroposterior diameter. Annular ring sutures will be placed circumferentially approximately 1 mm off the hinge point between the leaflet and the atrial tissue. The total number of sutures will vary between 4 and 7 sutures anteriorly, while 8 to 12 sutures will be utilized for the posterior segment of the annulus. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.; Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Heart Failure; Non-Ischemic Heart Failure; Mitral Regurgitation; Mitral Valve Replacement; Congestive Heart Failure; Surgical Mitral Valvuloplasty; Dilated Cardiomyopathy; Annular Ring

Summary:

      Mitral regurgitation (MR), also known as mitral insufficiency, is a condition in which the
      heart's mitral valve, located between two of the heart's main chambers, does not firmly shut,
      allowing blood to leak backwards within the heart. Improper functioning of the mitral valve
      disrupts the proper flow of blood through the body, resulting in shortness of breath and
      fatigue. When mild, MR may not pose a significant danger to a person's health, but severe MR
      may be associated with serious complications, such as heart failure, irregular heart rhythm,
      and high blood pressure. Although there are treatments for MR, including medication and
      surgery, more information is needed on the effectiveness of these treatments in people with
      significant MR. This study will compare the safety and effectiveness of corrective surgery
      added to optimal medical treatment (OMT) versus OMT alone in treating people with significant
      MR caused by an enlarged heart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic chronic heart failure, New York Heart Association (NYHA) class II to IIIb

          -  Left ventricular ejection fraction of 0.35 due to non-ischemic etiology

          -  Evidence by transthoracic echocardiography (TTE) of moderate or severe MR without
             obvious primary mitral valve pathology

          -  Peak VO2 less than or equal to 22 ml/kg/min, as obtained at study entry

          -  Optimal heart failure therapy for at least 6 months prior to study entry

        Exclusion Criteria:

          -  Significant coronary artery disease (greater than 75% lesion in any vessel) by
             coronary angiography or by a history of a prior heart attack

          -  Heart failure due to active myocarditis, congenital heart disease, or obstructive
             hypertrophic cardiomyopathy

          -  Significant ventricular arrhythmias not treated with an implantable defibrillator

          -  Primary MR due to significant chordal or leaflet abnormalities by TTE

          -  Other hemodynamically relevant stenotic or regurgitant valvular diseases

          -  Severe tricuspid regurgitation (TR) (moderate TR is allowed)

          -  Severe pulmonic regurgitation (PR) (moderate PR is allowed)

          -  Moderate to severe aortic regurgitation

          -  Any moderate to severe stenotic lesions using American Heart Association/American
             College of Cardiology (AHA/ACC) criteria 31

          -  Dependence on chronic inotropic therapy

          -  Restrictive cardiomyopathy or constrictive pericarditis

          -  Severe right ventricular dysfunction

          -  Baseline creatinine greater than or equal to 3 mg/dL or renal replacement therapy
             (chronic hemodialysis or peritoneal dialysis)

          -  Poor transthoracic sonographic windows precluding reasonable assessment of LV
             endocardial borders from apical imaging on TTE

          -  Inability to perform the spirometric exercise testing

          -  Significant chronic lung disease that might interfere with the ability to interpret
             the spirometric measurements, including home oxygen, forced expiratory volume in 1
             second (FEV1) less than 1.0 L/min, or exertional hypoxemia with saturations less than
             90%

          -  Any known neoplastic disease other than skin cancer

          -  Other terminal illness with a life expectancy less than 1 year

          -  Plan for percutaneous mitral valve procedure