Multicenter Randomized Clinical Trial To Evaluate Two Different Amiodarone Regimens To Maintain Sinus Rhythm After Electrical Cardioversion In Persistent Atrial Fibrillation
概览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Maintenance of sinus rhythm
概览
简要总结
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The goal of this clinical trial is to learn if reduced doses of amiodarone can treat atrial fibrillation (AF) effectively while minimizing toxic side effects in patients with persistent AF after electrical cardioversion. The main questions it aims to answer are:
- Can a reduced dose of amiodarone (100 mg/day) maintain sinus rhythm as effectively as the standard dose (200 mg/day) 12 months post electrical cardioversion?
- What are the adverse effects of the standard and reduced doses of amiodarone during 12 months post electrical cardioversion?
- How do genetic polymorphisms affect the efficacy and safety of amiodarone?
- How do amiodarone plasma levels correlate with the maintenance of sinus rhythm and genetic polymorphisms?
Researchers will compare the standard dose (200 mg/day) to the reduced dose (100 mg/day) to see if the reduced dose offers a better balance between efficacy and safety.
Participants will:
- Be treated with full dose amiodarone (200 mg/day) during the first month after electrical cardioversion.
- Be randomized to either continue with the full dose (200 mg/day) or switch to the reduced dose (100 mg/day).
The study is a multicenter, randomized clinical trial involving 312 patients with persistent AF after successful electrical cardioversion. Participants will be followed for 12-18 months to monitor the recurrence of AF and adverse effects.
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
- 18 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
Amiodarone full doses
Patients will receive amiodarone full doses (200 mg/day) (Usual dose)
干预措施: Amiodarone Hydrochloride 200 MG (Drug)
Amiodarone reduced doses
Patients will receive amiodarone reduced doses (100 mg/day)
干预措施: Amiodarone Hydrochloride 100 MG (Drug)
结局指标
主要结局
Maintenance of sinus rhythm
时间窗: 12 months follow-up
Number of patients mantaining sinus rhythm 12 months post electrical cardioversion
次要结局
- Plasma levels(12 months follow-up)
- Adverse effects(12 months follow-up)
- Polymorphisms(12 months follow-up)