NCT01198873终止4 期
A Placebo-Controlled, Double-Blind, Randomized, Multi-center Study to Assess the Effects of Dronedarone 400 mg BID on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 76
- 试验地点
- 57
- 主要终点
- Change From Baseline in Left Atrial Volume Index (LAVi)
研究概览
简要总结
Primary Objective:
- Evaluate the effect of dronedarone versus placebo (standard therapy) in slowing the progression of adverse left atrial remodeling in patients with atrial fibrillation (AF) following 12 months of treatment.
Secondary Objectives:
- Evaluate the effects of dronedarone versus placebo on left atrial function;
- Evaluate the effects of dronedarone versus placebo on left atrial dimension;
- Evaluate the effects of dronedarone versus placebo on left ventricular function (LVEF, E, E', A, E/E')
- Evaluate the safety and tolerability of dronedarone.
详细描述
The planned total study period per participant was 12 months and 3 weeks broken down as follows:
- Screening period: up to 1 week;
- Treatment period: 12 months;
- Follow-up period: 2 weeks.
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
- 21 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
Dronedarone
Experimental
Dronedarone 400 mg twice a day
干预措施: Dronedarone (Drug)
Placebo
Placebo Comparator
Placebo (for Dronedarone) twice a day
干预措施: Placebo (for Dronedarone) (Drug)
结局指标
主要结局
Change From Baseline in Left Atrial Volume Index (LAVi)
时间窗: baseline (before randomization) and post-baseline (after 3-12 months of treatment)
Left Atrial Volume index (LAVi) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis.
次要结局
- Changes From Baseline in Left Atrial Function(baseline (before randomization) and post-baseline (after 3-12 months of treatment))
- Changes From Baseline in Left Atrial Dimension(baseline (before randomization) and post-baseline (after 3-12 months of treatment))
- Changes From Baseline in Left Ventricular Ejection Fraction (LVEF)(baseline (before randomization) and post-baseline (after 3-12 months of treatment))
- Changes From Baseline in Left Ventricular Function(baseline (before randomization) and post-baseline (after 3-12 months of treatment))
研究者
研究点 (57)
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