The purpose of this study is to compare early mitral valve repair versus a watchful waiting strategy in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function.
Severe asymptomatic organic mitral valve (MV) regurgitation with preserved left ventricular (LV) function is a challenging clinical entity as data on the recommended treatment strategy for these patients are scarce and conflicting, which is reflected in current guidelines. European guidelines advocate a more conservative strategy i.e. watchful waiting, with yearly echocardiography, whilst American guidelines are more in favour of early surgery to reconstruct the MV, i.e. MV repair (in contrast to MV replacement) in order to prevent future LV dysfunction and complaints. A number of non-randomised trials show a favourable outcome of early surgery and the early surgery strategy has shown to be associated with improved long-term survival, decreased cardiac mortality and decreased morbidity compared with the conservative management \[citations 1-3\]. On the other hand, non-randomised trials describe also that a conservative strategy (i.e. watchful waiting) can be safely accomplished. If facilitated surgery is performed in this population it has proven to be eventually associated with good perioperative and postoperative outcome in 50% of the patients at 10 years when careful follow-up is being carried out \[citation 4\]. Non-randomised trials inherently have a number of drawbacks. A randomised trial comparing both strategies and objectivising the best treatment strategy has never been performed. The Dutch AMR (Asymptomatic Mitral Regurgitation) trial is a multicenter, prospective, randomised trial comparing early MV repair versus watchful waiting in asymptomatic patients with severe organic MV regurgitation and preserved LV function \[citation 5, 6\].
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
In case of watchful waiting a conservative treatment is performed, based on close monitoring of the patient for clear signs of deterioration that triggers facilitated surgery before left ventricular dysfunction is present.
Patients in the group of early mitral valve repair will be operated by way of routine mitral valve repair procedures in specialized centres.
Leiden University Medical Center
Leiden, South Holland, Netherlands
University Medical Center Utrecht (UMC Utrecht)
Utrecht, Utrecht, Netherlands
Amsterdam Medisch Centrum
Amsterdam, Netherlands
Amphia Hospital
Breda, Netherlands
Composite endpoint: cardiovascular mortality, congestive heart failure and hospitalization for nonfatal cardiovascular events
The primary outcome is defined as 'time to first event'. It concerns time to first event of the composite endpoint of cardiovascular mortality, congestive heart failure, non-fatal cardiovascular events requiring hospitalization, defined as: stroke/cerebrovascular accident (CVA), atrial fibrillation (permanent or requiring hospitalization) and/or reoperation after elective MV surgery.
Time frame: Min. 5 years
Cardiovascular mortality
Secondary outcome measures are the separate components of the composite primary endpoint: cardiovascular mortality, congestive heart failure, hospitalization for nonfatal cardiovascular events (stroke/cerebrovascular accident (CVA), AF (permanent or requiring hospitalization) and reoperation after elective MV surgery).
Time frame: Min. 5 years
Congestive heart failure
Secondary outcome measures are the separate components of the composite primary endpoint: cardiovascular mortality, congestive heart failure, hospitalization for nonfatal cardiovascular events (stroke/cerebrovascular accident (CVA), AF (permanent or requiring hospitalization) and reoperation after elective MV surgery).
Time frame: Min. 5 years
Hospitalization for nonfatal cardiovascular events
Secondary outcome measures are the separate components of the composite primary endpoint: cardiovascular mortality, congestive heart failure, hospitalization for nonfatal cardiovascular events (stroke/cerebrovascular accident (CVA), AF (permanent or requiring hospitalization) and reoperation after elective MV surgery).
Time frame: Min. 5 years
All-cause mortality
Secondary outcome measures the incidence of all-cause mortality at a minimum of 5 years.
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Time frame: Min. 5 years
Costs and effectiveness
Secondary outcome measures total direct and indirect costs and cost-effectiveness at a minimum of 5 years.
Time frame: Min. 5 years
Health-related quality of life
Secondary outcome measures health-related quality of life at a minimum of 5 years.
Time frame: Min. 5 years
Echocardiographic parameters
Secondary outcome measures echocardiographic parameters at a minimum of 5 years.
Time frame: Min. 5 years
CMR parameters
Secondary outcome measures Cardiovascular Magnetic Resonance imaging (CMR) parameters at a minimum of 5 years.
Time frame: Min. 5 years.
Paroxysmal atrial fibrillation
Secondary outcome measures the incidence of paroxysmal atrial fibrillation at a minimum of 5 years.
Time frame: Min. 5 years
Exercise test parameters
Secondary outcome measures exercise test parameters at a minimum of 5 years.
Time frame: Min. 5 years.
BNP
Secondary outcome measures brain natriuretic peptide (BNP) plasma levels at a minimum of 5 years.
Time frame: Min. 5 years
Myocardial infarction
Secondary outcome measures the incidence of myocardial infarction at a minimum of 5 years.
Time frame: Min. 5 years
Pacemaker implantation
Secondary outcome measures the incidence of pacemaker implantation at a minimum of 5 years.
Time frame: Min. 5 years
Transient ischemic attack
Secondary outcome measures the incidence of transient ischemic attack (TIA) at a minimum of 5 years.
Time frame: Min. 5 years
Pulmonary embolism
Secondary outcome measures the incidence of pulmonary embolism at a minimum of 5 years.
Time frame: Min. 5 years