NL-OMON36263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 (AFRODITE study) - AFRODITE
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 596
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Paroxysmal AF (according to ACC/AHA/ESC 2006 definition) 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.
- •> 45 years of age.
- •Anticoagulant treatment in line with local guidelines.
排除标准
- •Incapacitated patients.
- •Permanent AF (according to ACC/AHA/ESC 2006 definition).
- •Use of class I or III AADs in the past 3 months.
- •Patients scheduled for cardioversion or pulmonary vein ablation.
- •Unstable NYHA class III and all class IV HF.
- •AV block grade 2 or 3.
- •Known severe renal impairment (serum creatinine >180 µmol/l).
- •Known severe hepatic impairment (AST, ALT >3x 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 (in the opinion of the investigator).
- •Lactating women.
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