Asymptomatic severe Mitral Valve (MV) regurgitation with preserved left ventricular function is a challenging clinical entity as data on the recommended treatment strategy for these patients are scarce and conflicting.
Dutch AMR (Asymptomatic Mitral Regurgitation) is a multicenter registry comparing early MV repair versus watchful waiting in asymptomatic patients with severe organic MV regurgitation. Asymptomatic patients (18-70 yrs) with preserved left ventricular function will be included. Intervention will be either watchful waiting or MV surgery. Follow-up will be at least 5 years. Primary outcome measures are a composite endpoint of cardiovascular mortality, congestive heart failure, hospitalization for non-fatal cardiovascular and cerebrovascular events. Secondary outcome measures are all-cause mortality, total costs, cost-effectiveness, quality of life, echocardiographic and CMR parameters, exercise tests, asymptomatic atrial fibrillation and BNP levels. Additionally, complication rate in the surgery group and rate of surgery in the watchful waiting group will be determined.
We anticipate that the results of this study are highly needed to elucidate the best treatment strategy and may serve as an international landmark study.
Initially, Dutch AMR was iniated as a randomized trial, with an additional Registry arm. Over the last years we experienced that it was simply not possible to randomize enough patients within Dutch AMR, since most of them prefer to make a suitable treatment choice in shared decision making with their cardiologist, rather than draw a straw. See also our update.
Consequently, the steering committee decided (after consulting DSMB) to stop the randomization arm, and continu DUTCH AMR solely as a Registry trial.
DUTCH AMR is registered at clinicaltrial.gov: NCT01708265