Dutch AMR; Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Organic Mitral Regurgitation; a Multicenter, Randomised Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- UMC Utrecht
- 入组人数
- 12
- 试验地点
- 6
- 主要终点
- Composite endpoint: cardiovascular mortality, congestive heart failure and hospitalization for nonfatal cardiovascular events
研究概览
简要总结
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.
详细描述
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].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asymptomatic
- •Severe organic mitral valve regurgitation.
- •Preserved left ventricular function (left ventricular ejection fraction >60% and left ventricular end-systolic dimension ≤45 mm)
- •The likelihood of MV repair should be more than 90% determined by the local heart team with a cardiologist and cardiothoracic surgeon
排除标准
- •Pulmonary hypertension (>50 mmHg at rest)
- •Atrial fibrillation
- •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
- •Moderate to severe kidney disease (eGFR less than 30 mL/min)
- •Flail leaflet together with a left ventricular end systolic diameter (LVESD) >40 mm
结局指标
主要结局
Composite endpoint: cardiovascular mortality, congestive heart failure and hospitalization for nonfatal cardiovascular events
时间窗: Min. 5 years
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.
次要结局
- Cardiovascular mortality(Min. 5 years)
- Congestive heart failure(Min. 5 years)
- Hospitalization for nonfatal cardiovascular events(Min. 5 years)
- All-cause mortality(Min. 5 years)
- Costs and effectiveness(Min. 5 years)
- Health-related quality of life(Min. 5 years)
- Echocardiographic parameters(Min. 5 years)
- CMR parameters(Min. 5 years.)
- Paroxysmal atrial fibrillation(Min. 5 years)
- Exercise test parameters(Min. 5 years.)
- BNP(Min. 5 years)
- Myocardial infarction(Min. 5 years)
- Pacemaker implantation(Min. 5 years)
- Transient ischemic attack(Min. 5 years)
- Pulmonary embolism(Min. 5 years)