Rate Control in Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Ventricular rate
研究概览
简要总结
The purpose of this study is to compare the effect of metoprolol, verapamil, diltiazem and carvedilol on ventricular rate, working capacity and quality of life in patients with chronic atrial fibrillation.
详细描述
This is a randomised, single blinded, cross-over study comparing the efficacy of metoprolol 100 mg o.d., verapamil 240 mg o.d., diltiazem 360 mg o.d. and carvedilol 25 mg o.d. in reducing ventricular rate in atrial fibrillation. A total of 60 patients will be included, with a minimum of 20 women.Patients will receive each of the drug regimens in a random sequence. Each regimen will be administered for 3 weeks, ensuring that steady-state drug concentration will be attained and to provide an adequate washout of the previous treatment. Following each regimen, exercise ECG and Holter registration will be performed and patients will undergo laboratory evaluation and complete QoL-forms. They will then be started on the next randomly assigned treatment regimen, until the entire sequence of treatment schedules is completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Persistent or permanent atrial fibrillation with ventricular rate > 80/min at rest and/or > 100/min average at daytime.
- •Male or female, age > 18.
排除标准
- •Hypersensitivity or contraindication to metoprolol, verapamil, diltiazem or carvedilol.
- •Coronary heart disease or heart failure
- •Systolic blood pressure < 100 mmHg
- •AV-conduction disturbance
- •Severe hepatic or renal dysfunction
- •Thyrotoxicosis
- •Ongoing treatment with Digitalis
- •Pregnancy or lactation
研究组 & 干预措施
Metoprolol
Treatment with Metoprolol 100 mg x 1 for three weeks
干预措施: Metoprolol (Drug)
Diltiazem
Treatment with Diltiazem 360 mg x 1 for three weeks
干预措施: Diltiazem (Drug)
Verapamil
Treatment with Verapamil 240 mg x 1 for three weeks
干预措施: Verapamil (Drug)
Carvedilol
Treatment with Carvedilol 25 mg x 1 for three weeks
干预措施: Carvedilol (Drug)
结局指标
主要结局
Ventricular rate
时间窗: Three weeks
Ventricular rate evaluated after three weeks on study drug treatment
次要结局
未报告次要终点
研究者
Sara Reinvik Ulimoe
MD
Asker & Baerum Hospital