Status:
TERMINATED
Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Heart Failure Clinical Research Network
Conditions:
Mitral Valve Insufficiency
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
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 ventricl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00608140
Start Date
March 1 2008
End Date
March 1 2010
Last Update
April 4 2018
Active Locations (9)
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1
Morehouse School of Medicine
Atlanta, Georgia, United States, 30310
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Minnesota Heart Failure Network
Minneapolis, Minnesota, United States, 55415
4
Mayo Clinic
Rochester, Minnesota, United States, 55905