Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Recurrence of atrial fibrillation
研究概览
简要总结
Atrial fibrillation and inflammation are strongly correlated. The aim of this study is to evaluate whether inflammation markers (alpha Defensin) predict maintenance of sinus rhythm following cardioversion. A secondary aim is to evaluate the role of Colchicine, an anti-inflammatory medication, in reducing the recurrence rate of atrial fibrillation.
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
- Double (Participant, Investigator)
盲法说明
Investigator and participants will be blinded regarding levels of anti-inflammatory markers
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
- •Atrial fibrillation
- •Candidate for cardioversion
排除标准
- •Colchicine allergy
- •Hepatic or renal failure
研究组 & 干预措施
Treatment group
This arm will undergo cardioversion followed by Colchicine (0.5 mg 2x per day) for six months
干预措施: Colchicine Tablets (Drug)
Treatment group
This arm will undergo cardioversion followed by Colchicine (0.5 mg 2x per day) for six months
干预措施: Cardioversion (Procedure)
结局指标
主要结局
Recurrence of atrial fibrillation
时间窗: 12 months
Atrial fibrillation recurrence rates over the next 12 months will be determined based on medical records and ECG documentation between treatment group (Colchicine) and control group.
次要结局
- Alpha Defensin levels in patients with recurrence of atrial fibrillation(12 months)
