Comparison of (R) and (S) Propafenone for Prevention of Atrial Fibrillation Induction
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- Number of Participants With Successful Induction of 30 Seconds of Atrial Fibrillation/Atrial Flutter
研究概览
简要总结
Propafenone is a currently used medicine to treat atrial fibrillation and is a mixture of two compounds, (R)-propafenone and (S)-propafenone. In this study, the investigators will randomize participants to (R)-propafenone, (S)-propafenone, or placebo.
详细描述
Atrial fibrillation is a common cardiac arrhythmia that needs development of more effective medications. Propafenone is a medicine currently used to treat atrial fibrillation and is a mixture of two compounds, (R)-propafenone and (S)-propafenone. The investigators have discovered that purified (R)-propafenone may be more effective than (S)-propafenone for treatment of atrial fibrillation, and that (S)-propafenone reduces the efficacy of (R)-propafenone when administered as a mixture. This study will compare the ability of (R)-propafenone, (S)-propafenone, and placebo to suppress the induction of atrial fibrillation in participants undergoing an atrial fibrillation ablation procedure.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
(R)-propafenone
Single intravenous dose of (R)-propafenone (2mg/kg) infused over 10 minutes
干预措施: (R)-propafenone (Drug)
(S)-Propafenone
Single intravenous dose of (S)-propafenone (2mg/kg) infused over 10 minutes
干预措施: (S)-Propafenone (Drug)
Placebo
Placebo (normal saline) is infused over 10 minutes
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Successful Induction of 30 Seconds of Atrial Fibrillation/Atrial Flutter
时间窗: Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)
A rapid atrial pacing protocol was used to attempt to induce atrial fibrillation/atrial flutter. Twenty minutes after start of the study drug, participants underwent placement of a decapolar coronary sinus catheter. Pacing was performed from the proximal electrode at 20 milliamps and a pulse width of 2 ms. Bursts from the CS proximal electrode were induced to attempt atrial fibrillation.
次要结局
- Number of Participants With Successful Inducibility of Atrial Fibrillation/Atrial Flutter Expressed as an Ordinal Variable Based on Stage of the Induction Protocol(Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes))
- Number of Participants With Successful Induction of 30 Seconds of Atrial Flutter(Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes))
研究者
Bjorn Knollmann
Professor of Medicine and Pharmacology
Vanderbilt University