Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 523
- 试验地点
- 23
- 主要终点
- Total Number of Days in Hospital
研究概览
简要总结
The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in hospital within 60 days of the occurrence of AF compared to a strategy of rate control.
详细描述
The purpose of the research is to compare two strategies for treating atrial fibrillation or atrial flutter, both of which are referred to as AF, after cardiac surgery. AF is the most common complication after cardiac surgery. AF is when the upper chambers of the heart (atria) experience disorganized electrical activity which causes the heart beat to be irregular. The two treatment strategies to be used in this study are called rhythm control and rate control. The rhythm control strategy will attempt to bring the heart beat back to a regular rhythm using treatments known and approved to control heart rhythm. The rate control strategy will attempt to bring the heart rate to less than 100 beats per minute at rest using medications known and recommended to control heart rate. Both strategies are commonly used to treat AF. All of the medications that will be used in this study are the standard of care for use in patients experiencing AF. This research seeks to determine whether rhythm control is better than rate control in patients with AF after cardiac surgery.
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
- •Age > 18 years
- •Undergoing heart surgery for coronary artery bypass (on-pump or off-pump CABG) and/or valve repair or replacement (excluding mechanical valves), including re-operations
- •Hemodynamically stable
- •Randomization Inclusion Criteria
- •AF that persists for > 60 minutes or recurrent (more than one) episodes of AF up to 7 days after surgery during the index hospitalization.
排除标准
- •LVAD insertion or heart transplantation
- •Maze procedure
- •History of or planned mechanical valve replacement
- •Correction of complex congenital cardiac defect (excluding bicuspid aortic valve, atrial septal defect or PFO)
- •History of AF or AFL
- •History of AF or AFL ablation
- •Contraindications to warfarin or amiodarone
- •Need for long-term anticoagulation
- •Concurrent participation in an interventional (drug or device) trial
研究组 & 干预措施
Rhythm control
Rhythm Control in post-operative AF
Amiodarone and/or DC-cardioversion
Amiodarone Initial Dose
- Oral: 400 mg po TID for 3 days is recommended
- For patients incapable of taking oral: 150 mg IV bolus over 10 min, then 1 mg/min over 6 hours followed by 0.5 mg/min over 18 hours Maintenance Dose
- Oral: at least 200 mg/day to be continued until 60 days after randomization
- If drug cannot be given orally or via NG tube: 0.5 mg/min administered through central line (e.g., PICC) until oral dosing is started
DC-Cardioversion - frequency and duration determined by medical professional as medically needed
干预措施: Amiodarone (Drug)
Rhythm control
Rhythm Control in post-operative AF
Amiodarone and/or DC-cardioversion
Amiodarone Initial Dose
- Oral: 400 mg po TID for 3 days is recommended
- For patients incapable of taking oral: 150 mg IV bolus over 10 min, then 1 mg/min over 6 hours followed by 0.5 mg/min over 18 hours Maintenance Dose
- Oral: at least 200 mg/day to be continued until 60 days after randomization
- If drug cannot be given orally or via NG tube: 0.5 mg/min administered through central line (e.g., PICC) until oral dosing is started
DC-Cardioversion - frequency and duration determined by medical professional as medically needed
干预措施: DC-cardioversion (Procedure)
Rate control
Rate Control in post-operative AF
Beta-blocker and/or Calcium channel blockers and/or Digoxin
Dose, frequency and duration determined by medical professional as medically needed
干预措施: Rate Control (Drug)
结局指标
主要结局
Total Number of Days in Hospital
时间窗: Within 60 days of randomization
The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.
次要结局
- Cost (Hospital)(Within 60 days of randomization)
- Heart Rhythm Comparison(60 days after randomization)
- AF- or Treatment-related Events(Within 60 days of randomization)
- Time to Conversion to Sustained, Stable Non-AF Rhythm(Up to index hospital discharge or 7 days post surgery, whichever came first)
- Length of Stay (Index Hospitalization)(Within 60 days post surgery)
- Length of Stay (Rehospitalization, Including ED Visits)(Within 60 days of randomization)
- Outpatient Interventions(Within 60 days of randomization)
研究者
Annetine Gelijns
Professor and Chair, Health Evidence and Policy
Icahn School of Medicine at Mount Sinai