WithDRawal Impact Of Postoperative Beta-Blocker
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Peak oxygen consumption (VO2 max) to measure cardiorespiratory fitness
研究概览
简要总结
The investigators will evaluate the impact of withdrawing beta-blocker medication after coronary artery bypass surgery with this randomized controlled trial.
详细描述
Aim 1: The primary aim is to evaluate the impact of withdrawing BB on exercise capacity (peak oxygen consumption, VO2 max) in patients who underwent CABG. The investigators hypothesize that withdrawing BB 1 month after CABG will improve exercise capacity 2 months after CABG.
Aim 2: The secondary objectives are to evaluate the impact of withdrawing BB on a MACCE (major adverse cardiac and cerebrovascular event) and fatigue-related symptoms in patients who underwent CABG. The investigators hypothesize that withdrawing BB after CABG for 1 year will be non-inferior to continuing BB in terms of MACCE incidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Blinding will be only on the investigator interpreting CPET and adjudicating major cardiac and cerebrovascular events
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
- •Participants who underwent coronary artery bypass graft(CABG) surgery at Yale New Haven Hospital who presented to 1-month postoperative visit
- •ejection fraction >50%, and in sinus rhythm at the time of hospital discharge or enrollment.
排除标准
- •those who underwent combined valve + CABG surgery or aorta + CABG surgery.
结局指标
主要结局
Peak oxygen consumption (VO2 max) to measure cardiorespiratory fitness
时间窗: 1 month
Peak oxygen measured in ml/kg/min consumption will be measured on CPET 1 month after randomization and be compared controls. This is an important measure of exercise capacity, which has been shown to decrease in other population when on beta-blocker. The higher the measure, the better with measures greater than 12.3 ml/kg/min as positive.
次要结局
- Change in fatigue measured using the Fatigue Assessment Scale (FAS)(baseline and 3 months)
- Change in activity level measured using the Veterans Specific Activity Questionnaire(VSAQ)(baseline and 3 months)
- Adherence to medication and adjudication of endpoint(12 months)
- Change in vertigo symptoms measured using the Vertigo Symptom Scale-short form(baseline and 3 months)