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临床试验/NCT04155879
NCT04155879Unknown不适用

Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels

Hillel Yaffe Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年11月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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