Comparing early mitral valve repair to watchful waiting for asymptomatic patients with severe mitral regurgitation
Dutch-AMR Study: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Organic Mitral Regurgitation and Preserved Ejection Fraction: a Multicenter Registry Trial
This study is testing whether early surgery to fix a leaky heart valve is better than just keeping an eye on it for people who don't have symptoms but have severe mitral regurgitation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 6 sites (Amsterdam and 5 other locations) |
| Trial ID | NCT03975998 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the outcomes of early mitral valve repair versus a conservative watchful waiting approach in asymptomatic patients diagnosed with severe organic mitral regurgitation. The study addresses the conflicting treatment strategies recommended by European and American guidelines, focusing on the potential benefits of early surgical intervention to prevent future left ventricular dysfunction. Participants will be monitored through echocardiography to assess their condition over time. The study seeks to provide clarity on the optimal management of this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are asymptomatic adults aged 18-75 with severe organic mitral valve regurgitation and preserved left ventricular function.
Not a fit: Patients with symptomatic mitral regurgitation or those with significant left ventricular dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the most effective treatment strategy for asymptomatic patients with severe mitral regurgitation, potentially improving long-term outcomes.
How similar studies have performed: Previous non-randomized trials have shown favorable outcomes for early surgical intervention in similar patient populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-75 years. * Asymptomatic patients. "Asymptomatic" is defined as absence of subjective limitations of exercise capacity or complaints expressed by the patient and confirmed by the treating cardiologist. * Severe organic mitral valve regurgitation. "Severe organic mitral valve regurgitation" is defined as non-ischemic mitral valve regurgitation with an organic cause (intrinsic valve lesion) as determined by echocardiographic core-lab reading based on the criteria for definition of severe MR as issued by the ESC guidelines \[4\]. For practical reasons, referring cardiologists can use an ESC guidelines based index that was validated in the investigator's core-lab (Jansen et al, Practical echocardiographic semi-quantitative scoring system to determine severity of mitral regurgitation. Abstract presentation at ESC EUROECHO Congress 2011 and annual spring congress 2012 Netherlands Society of Cardiology). * Preserved left ventricular function, "Preserved left ventricular function" is defined as left ventricular ejection fraction \>60% and left ventricular end-systolic dimension \<45 mm (no indexed value, measured by echocardiography). * The likelihood of MV repair should be more than 90% determined by the local heart team with a cardiologist and cardiothoracic surgeon. Exclusion Criteria: * Pulmonary hypertension (\>50 mmHg at rest). * Atrial fibrillation, either on 12-lead ECG or holter-monitoring. * Physical inability as determined by the heart team to undergo surgery. * Other life-threatening morbidity. * Higher expected surgical risks in advance, according to the dedicated heart team. * Patients with moderate to severe kidney disease (estimated glomerular filtration rate (eGFR) less than 30 mL/min). * Flail leaflet together with a left ventricular end systolic diameter (LVESD) ≥40 mm (no indexed value)
Where this trial is running
Amsterdam and 5 other locations
- Amsterdam Medical Center (AMC) — Amsterdam, Netherlands (Recruiting)
- Amphia Breda — Breda, Netherlands (Recruiting)
- Medisch Spectrum Twente (MST) — Enschede, Netherlands (Recruiting)
- Leiden University Medical Center (LUMC) — Leiden, Netherlands (Active_not_recruiting)
- Maastricht UMC — Maastricht, Netherlands (Recruiting)
- University Medical Center Utrecht (UMC Utrecht) — Utrecht, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.