Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significan… (NCT00608140) | Clinical Trial Compass
TerminatedPhase 3
Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure
Stopped: Unable to recruit sufficient numbers of patients.
United States, Canada2 participantsStarted 2008-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 hemodialysi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of Adding SMVR to OMT Alone on LV Remodeling, Specifically LV End-systolic Volume Index (LVESVI)