Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure: RACE 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 20
- 主要终点
- Success of rhythm control strategy consisting of 1) the patient is still in a rhythm control strategy according to the attending physician, and 2) that sinus rhythm is maintained after 1 year of follow-up.
研究概览
简要总结
The purpose of this study is to investigate whether in patients with early persistent atrial fibrillation and mild to moderate early heart failure an aggressive upstream rhythm control approach, including aldosterone receptor antagonists and statins, dietary restrictions, counseling and cardiac rehabilitation programs, increases persistence of sinus rhythm compared with conventional rhythm control after one year of follow-up.
A randomized long term extension of the RACE 3 will be performed with a total follow-up of 5 years to investigate the long term effects on persistence of sinus rhythm and cardiovascular morbidity and mortality of the two treatment strategies.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Early symptomatic persistent atrial fibrillation
- •Mild to moderate early heart failure
- •Optimal documentation and treatment of underlying heart disease
- •No contra-indication for oral anticoagulation
- •Eligible for cardiovascular rehabilitation
- •Age >= 40 years
排除标准
- •On waiting list for pulmonary vein isolation or expected to be placed on waiting list within one year
- •Heart failure NYHA class IV
- •LVEF < 25%
- •Left atrial size > 50 mm (parasternal axis)
- •Present aldosterone receptor antagonist use
- •Previous use of class I or III antiarrhythmic drugs (except for sotalol, which should be discontinued at inclusion and replaced with betablocker)
- •Cardiac resynchronization therapy
结局指标
主要结局
Success of rhythm control strategy consisting of 1) the patient is still in a rhythm control strategy according to the attending physician, and 2) that sinus rhythm is maintained after 1 year of follow-up.
时间窗: 1 year after electrical cardioversion
次要结局
- Exploratory randomized long term extension of the RACE 3 study performed to study the long term effects of the two treatment strategies.(5 years after electrical cardioversion)
研究者
I.C. Van Gelder
Prof.
University Medical Center Groningen