Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery : a Randomized Multicenter Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery
研究概览
简要总结
Postoperative atrial fibrillation is a common complication after cardiac surgery with a rate of 30%. However, management of postoperative atrial fibrillation is controversial. Two strategies are recommended : heart rate control using a betablocker or rhythm control with amiodarone.
Landiolol is a new-generation beta-blocker with a short half-life, which was approved by the Haute Autorité de Santé to be used in perioperative supra-ventricular tachycardias.
Only one study compared landiolol to amiodarone in the perioperative setting, with a better hemodynamic tolerance and a higher rate of conversion to sinus rhythm with landiolol. However this was a single-center and retrospective study.
The aim of our multicenter randomized study is to compare the effectiveness of landiolol in reducing atrial fibrillation to sinus rhythm compared to amiodarone in the postoperative period after cardiac surgery.
详细描述
Randomized clinical study comparing landiolol and amiodarone for treatment of atrial fibrillation following 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
- •Adult patients hospitalized in the cardiac ICU after having undergone cardiac surgery (CABG, aortic valve or ascending aortic root replacement or a combination of both)
- •New onset of atrial fibrillation lasting more than 30 minutes in the postoperative period after cardiac surgery
- •French speaking patients
- •Written consent
- •Patients with social security insurance
排除标准
- •Hemodynamic instability requiring electrical cardioversion of atrial fibrillation
- •Bradyarrythmia (< 90/min)
- •Patients requiring inotropes in the postoperative period
- •Patient with pre-existing atrial fibrillation
- •Patient with anticoagulant therapy before surgery
- •Contraindication to amiodarone or beta-blockers
- •Urgent surgery (< 24h), ventricular assist device, heart transplant, TAVR, mechanical valve, mitral or tricuspid valve replacement.
- •No written consent
- •Pregnant women,
- •Underaged patients (<18 years old)
- •Patients not able to give consent (curators, patients deprived of public rights)
研究组 & 干预措施
Landiolol
Landiolol infusion starting at 2.5 µg/kg/min and titrating up to 80µg/kg/min with a heart rate goal of under 90 bpm.
干预措施: Landiolol (Drug)
Amiodarone
Amiodarone bolus of 5-7 mg/kg in 1 hour, followed by an infusion of 1g/day until conversion to sinus rhythm.
干预措施: Amiodarone (Drug)
结局指标
主要结局
Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery
时间窗: Day 2 after onset of atrial fibrillation
Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery
次要结局
- Quality of life evaluated by the EQ 5D 3L questionnaire(2 months postsurgery and 1 year postsurgery)
- Severe hemorrhagic complications due to anticoagulant therapy, as defined by the Haute Autorité de Santé(2 months postsurgery and 1 year postsurgery)
- Rate of atrial fibrillation recurrence(2 months postsurgery and 1 year postsurgery)
- Length of hospital stay(Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days)
- Rate of thrombo-embolic events(2 months postsugery and 1 year postsurgery)
- Haemodynamic side effects (hypotension, bradycardia)(Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days)