跳至主要内容
临床试验/NCT00791089
NCT00791089终止4 期

Effect of Omega-3 Fatty Acids on Short and Long-Term Maintenance of Sinus Rhythm After Radiofrequency Catheter Ablation for Atrial Fibrillation

University of Michigan1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
12
试验地点
1
主要终点
Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias)

研究概览

简要总结

To determine if peri-operative treatment with omega-3 fatty acids is associated with a decrease in the incidence of early recurrences of atrial arrhythmias (within 30 days) and an improvement in probability of long-term maintenance of sinus rhythm after radiofrequency catheter ablation for Atrial Fibrillation.

详细描述

AF is the most prevalent arrhythmia, affecting >2 million Americans. Antiarrhythmic drug therapy often is ineffective to eliminate recurrent episodes of AF. In recent years radiofrequency catheter ablation has emerged as a highly effective treatment strategy in patients with paroxysmal and chronic AF.6, 7 However, AF may recur within days to weeks after a successful ablation procedure in up to 50% of the patients, probably because of an inflammatory response to thermal injury caused by radiofrequency energy application. These early recurrences of AF after ablation do not necessarily predict long-term clinical outcome and 30-50% of patients who develop early recurrences ultimately remain in sinus rhythm without the need for additional ablation.8 However, early recurrences of AF may be associated with significant morbidity due to troubling symptoms of rapid ventricular rates, multiple hospital visits and cardioversions, need for antiarrhythmic drug therapy and prolongation in duration of anticoagulant therapy. It is also possible that if early recurrences of AF after ablation can be avoided, the probability of remaining in sinus rhythm during long-term follow-up may be higher, as maintenance of sinus rhythm early-on may facilitate reverse left atrial remodeling. A similar phenomenon may occur in post-operative AF, that develops in ~30% of patients who undergo cardiac surgery. Post-operative AF is often transient and usually resolves within 3 months after the surgery. Perioperative treatment with omega-3 fatty acids has been reported to decrease the incidence of postoperative AF after coronary artery by-pass surgery.4 Because the pathogenetic factors that play a role in postoperative AF and early recurrences of AF after radiofrequency catheter ablation may be similar, it is plausible that treatment with omega-3 fatty acids before and after ablation will be associated with a reduction in the incidence of early recurrences of AF.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years and < 70 years old
  • Left atrial size <55 mm

排除标准

  • Inability or unwillingness to provide informed consent
  • Current therapy with omega-3 fatty acids
  • Current therapy with a statin
  • Active liver disease
  • Significant comorbidity such as end-stage renal disease or cirrhosis
  • Valvular prosthesis

研究组 & 干预措施

Fish Oil, Ablation, Sinus Rhythm

Experimental

Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.

干预措施: LOVAZA Omega 3-acid ethyl esters (Drug)

Fish Oil, Ablation, Sinus Rhythm

Experimental

Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.

干预措施: LOVAZA (Drug)

placebo, Ablation, sinus rhythm

Placebo Comparator

Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.

干预措施: placebo (Other)

结局指标

主要结局

Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias)

时间窗: 6 months

Freedom from atrial arrhythmias at 6 months will be defined as absence of any atrial arrhythmias with or without antiarrhythmic drug (AAD) therapy as shown in the two lines

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hakan Oral

Cardiology EP Director

University of Michigan

研究点 (1)

Loading locations...

相似试验