TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8,505
- 试验地点
- 109
- 主要终点
- Incidence rate of the composite of "all-cause death, nonfatal reinfarction, or heart failure hospitalization" (MACE)
研究概览
简要总结
REBOOT clinical trial will study whether long-term maintenance beta-blockers therapy results in a clinical benefit after heart attack without reduced left ventricular function. Half of the participants will be randomized to receive long-term beta-blocker therapy and the other half to no beta-blocker therapy after hospital discharge. All patients will be followed up for up to 5 years to determine the occurrence of adverse events (all cause mortality, re-infarction, and heart failure admission).
详细描述
Pragmatic, controlled, prospective, randomized, open-label, blinded endpoint clinical trial testing the benefits of beta-blocker maintenance therapy in patients discharged after an acute myocardial infarction (MI). Patients being discharged after an acute MI, with or without ST-segment elevation, and with a left ventricular ejection fraction >40%, and without history of heart failure (HF) prior to study inclusion, will be recruited. At discharge, patients will be randomized (1:1) to receive beta-blocker therapy (agent and dose according to treating physician) or no beta-blocker therapy. Primary outcome is the 5 years incidence of MACE (all cause mortality, reinfarction, heart failure admission).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Admitted for STEMI or NSTEMI and invasive management (i.e. coronary angiography during index hospitalization).
- •LVEF>40% as evaluated by any imaging technique anytime during hospitalization.
- •Signed informed consent
排除标准
- •Known allergy or intolerance to beta-blockers
- •Absolute contraindication to beta-blocker therapy according to treating physician judge
- •Prior history of HF, Killip class on admission or during hospitalization ≥ II
- •Severe valvular heart disease (> 3+ for aortic or mitral insufficiency, aortic or mitral valve area ≤1.0 cm2).
- •Any condition (appart from AMI) that requires beta-blocker prescription on discharge according to treating physician judge
- •Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year),
- •Patients participating in other clinical trials
研究组 & 干预措施
Beta-blocker therapy
This is a strategy (pragmatic) trial. In patients allocated to "Beta-blocker therapy", beta blocker agent and dose are decided by treating physician.
betablocker therapy chosen might be any of the following: atenolol bisoprolol carvedilol metoprolol nebivolol
干预措施: Beta blocker (Drug)
结局指标
主要结局
Incidence rate of the composite of "all-cause death, nonfatal reinfarction, or heart failure hospitalization" (MACE)
时间窗: 12-54 months since the beginning (median follow up anticipated 3.75 years)
absolute number of patients experiencing deaths will be added to number of patients experiencing a non fatal reinfarction and to number of patients experiencing heart failure hospitalization. If a patient experience more than one of these events, only first event will be added for the sum of events EXAMPLE events in arm 1: 150 deaths+150 reinfarctions+150 heart failure hospitalizations= TOTAL 450 MACE (450 events/4234 patients enroled: event rate 10.63%)
次要结局
- 2.1 Incidence rate of individual components of the primary outcome. 2.2 Incidence rate of cardiac mortality. 2.3 Incidence of sustained ventricular tachycardia/ventricular fibrillation (VT/VF) and resuscitated cardiac arrest.(12-54 months since the beginning (median follow up anticipated 3.75 years))