N-3 Polyunsaturated Fatty Acids (n-3 PUFAs) in the Prevention of Atrial Fibrillation Recurrences After Electrical Cardioversion. A Prospective Randomized Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)
研究概览
简要总结
The purpose of this study is to determine the effect of n-3 PUFAs in addition to amiodarone and renin-angiotensin-aldosterone system (RAAS) inhibitors on the maintenance of sinus rhythm after electrical conversion in patients with persistent Atrial fibrillation (AF).
详细描述
Atrial fibrillation (AF) is the most common sustained arrhythmia and represents an increasing burden on the healthcare system. Treatment of AF remains controversial. In patients on antiarrhythmic therapy, the one-year relapse rates of AF after cardioversion ranges from 44% to 77% at one year and amiodarone appears to the be the most effective in maintaining sinus rhythm.Over the last few years, a growing amount of evidences has supported the protective effects of n-3 PUFAs in preventing ventricular arrhythmias and reducing the risk of sudden cardiac death. Furthermore, in the last years, the interest for their possible beneficial role in AF prevention has been increasing.We hypothesized that the administration of n-3 PUFAs could reduce the AF recurrence rate more than amiodarone plus RAAS inhibitors in patients with persistent AF. Therefore the present study aims to evaluate the role of n-3 PUFAs in the prophylaxis of AF recurrences after DCCV in addition to amiodarone and RAS blockers therapy in patients with persistent AF.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •persistent Atrial Fibrillation (AF) lasting > one month
- •history of at least one AF relapse after previous electrical or Pharmacological cardioversion
排除标准
- •left atrium size > 6 cm
- •severe valvulopathy
- •myocardial infarction during the previous 6 months
- •unstable angina
- •NYHA heart failure class IV or hemodynamic instability
- •cardiac surgery during the previous 3 months
- •significant pulmonary thyroid and hepatic disease
- •contraindications to treatment with amiodarone or RASS inhibitors
- •chronic renal dysfunction
- •QT > 480 msec in the absence of bundle-branch block
- •bradycardia < 50 b/min
- •diagnosis of paroxysmal AF
- •hyperkalemia
- •pregnancy
- •any disease or other medical treatment that, in the opinion of the investigators, could interfere with the study.
研究组 & 干预措施
n-3 PUFAs
干预措施: n-3 PUFAs (Drug)
n-3 PUFAs
干预措施: RASS inhibitors and/or RAS blockers (Drug)
n-3 PUFAs
干预措施: Amiodarone (Drug)
placebo
干预措施: Placebo (Drug)
placebo
干预措施: RASS inhibitors and/or RAS blockers (Drug)
placebo
干预措施: Amiodarone (Drug)
结局指标
主要结局
Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)
时间窗: one year
Sinus Rhythm maintenance means no Atrial Fibrillation recurrence at one-year follow up. Patients with successful electrical cardioversion (DCCV)underwent weekly clinical and electrocardiographic controls for the first three weeks following cardioversion. Subsequently, follow up visits with performance of clinical evaluation, ECG, and a 24-hour Holter monitoring were performed at 1, 3, 6 and 12 months after DCCV.
次要结局
- The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence(1, 3 and 6 months)
研究者
Savina Nodari
N-3 Polyunsaturated Fatty Acids (n-3 PUFAs) in the Prevention of Atrial Fibrillation Recurrences After Electrical Cardioversion. A Prospective Randomized Study.
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia