NCT00352560已完成3 期
Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients.
研究概览
简要总结
The main purpose of the study is to compare the mean AERP between treatment groups based on the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent PAF with indication for catheter ablation
排除标准
- •Struct. Cardiopathy
- •Mitral valve disease
- •Myocardiopathy
- •cardiac surgery
- •AF reversible
- •QT c>450
- •Recent MI/stroke, severe HTN
- •Requirement of ACEI/ARBs
- •Coronary synd., HTA, liver disease
研究组 & 干预措施
A
Active Comparator
干预措施: Irbesartan (Drug)
B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients.
时间窗: The measures are taken after 31 days of irbesartan treatment
次要结局
- Irbesartan effect on A Function RP(The measures are taken after 31 days of irbesartan treatment)
- Irbesartan effect on atrial conduction intervals after basal & extra-stimuli, in PAF patients(The measures are taken after 31 days of irbesartan treatment)
- Refractoriness dispersion(The measures are taken after 31 days of irbesartan treatment)
研究者
研究点 (1)
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