Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to first detected AF
研究概览
简要总结
The purpose of this study is to determine the effect of statin therapy for prevention of atrial fibrillation (AF) in pacemaker and non-pacemaker patients with paroxysmal atrial fibrillation in the absence of significant coronary artery disease.
详细描述
Patients with a history of paroxysmal atrial fibrillation, with or without a dual chamber pacemaker and who meet all study criteria, will be randomized to receive either a placebo, or simvastatin 40 mg, daily for 6 months.
Liver enzymes are drawn at randomization and 3 months. CRP and oxidative stress products are drawn at randomization, weekly for the first month and then monthly for 5 months.
Patients transmit their rhythm, twice daily for 5 consecutive days at randomization, then 5 consecutive days monthly for 6 months.
Clinic visits are required at randomization, 3 months and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Patients with paroxysmal AF (> 3 epis each > 15 min in length) over 6 months
- •Patients on stable antiarrhythmic drug therapy and life expectancy > 1 year
排除标准
- •Patients with PAF due to reversible cause
- •Chronic inflammatory conditions
- •Other medical conditions requiring statin therapy
- •Patients on amiodarone or verapamil
- •Elevated CK or ALT
- •Life expectancy <1 year
- •TAVN ablation
- •Geographic isolation
- •Inability to give informed consent
研究组 & 干预措施
1
Patients randomized to active drug, then AF burden and CRP values will be compared to those in placebo arm.
干预措施: Simvastatin (Drug)
2
Patients take placebo once daily for 6 Months, then AF burden and CRP values will be compared to those in experimental arm.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first detected AF
时间窗: 6 Months
次要结局
- Changes in CRP and oxidative stress levels over time and their relationship with AF burden(6 Months)
研究者
Dr. Anne M. Gillis
MD
University of Calgary