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

• Status: Terminated
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborators: Heart Failure Clinical Research Network; National Heart, Lung, and Blood Institute (NHLBI)

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