NCT01047566已完成4 期
The Effect of the Addition of Dronedarone to, Versus Increase of, Existing Conventional Rate Control Medication on Ventricular Rate During Persistent Atrial Fibrillation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Ventricular rate
研究概览
简要总结
The primary objective of this study is to:
Assess whether the addition of dronedarone to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy.
The secondary objectives of this study are to compare both study arms with regard to:
- Ventricular rate after 3 months
- Number of registered AF episodes
- Number of symptomatic AF episodes
- Severity of AF and AF-like symptoms
- Rate of premature study discontinuation
- Number of symptomatic episodes of bradycardia
- Incidence of low heart rate (<60 bpm)
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
- 46 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent AF with HR >80 bpm at rest despite treatment with ≤ 2 rate control agents (i.e. beta blocker and/or calcium antagonist - Patients using digoxin are eligible)
- •Documented AF in the past 24 hours
- •Treated with the following rate control medication:
- •beta blocker or
- •calcium antagonist or
- •beta blocker plus calcium antagonist or
- •beta blocker plus digoxin or
- •calcium antagonist plus digoxin
- •Anticoagulant treatment in line with local guidelines
排除标准
- •Incapacitated patients
- •Paroxysmal or permanent AF
- •Use of class I or III anti-arrhythmic drugs in the past 12 weeks
- •Scheduled cardioversion or pulmonary vein ablation
- •Unstable New York Heart Association (NYHA) class III and all class IV Heart Failure
- •AV block grade 2 or 3
- •Known severe renal impairment (serum creatinine > 180 μmol/l)
- •Known severe hepatic impairment (AST, ALT > 3 x Upper Limit of Normal (ULN))
- •Contra-indication for dronedarone
- •Participation in a clinical drug study in the 3 months prior to inclusion
- •Women of childbearing potential, who do not use adequate contraception
- •Lactating women
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Addition of dronedarone
Experimental
Addition of Dronedarone to existing rate control medication (beta blocker and/or calcium antagonist)
干预措施: Dronedarone (Drug)
Dose Increase
Active Comparator
Dose increase of existing rate control medication (beta blocker or calcium antagonist or digoxin)
干预措施: Beta blocker or calcium antagonist or digoxin (Drug)
结局指标
主要结局
Ventricular rate
时间窗: One week
次要结局
- Ventricular rate(12 weeks)
- Patients with registered AF episodes(Within the 12 weeks after randomization)
- Patients with symptomatic episodes of bradycardia(Within the 12 weeks after randomization)
- Patients with symptomatic AF episodes(Within the 12 weeks after randomization)
- Severity of AF and AF-like symptoms(Within the 12 weeks after randomization)
- Premature study discontinuation(Within the 12 weeks after randomization)
- Patients with low heart rate (<60 bpm)(Within the 12 weeks after randomization)
研究者
研究点 (1)
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