Effect of Supplemental Intake of Omega-3 Polyunsaturated Fatty Acids on the Rate and Complexity of Spontaneously Occurring Ventricular and Supraventricular Arrhythmias in Patients With Implantable Cardioverter Defibrillator (ICD) - A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- number of VT/VF episodes
研究概览
简要总结
We hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of arrhythmic events among post-MI, ICD recipients.
详细描述
This is a randomized, placebo-controlled, crossover, double- blind interventional study. Patients will receive 3.6 g of EPA and DHA fish oil and placebo oil for 6 months, randomly, in a crossover design, with a four month washout period between treatments.
Randomization will be stratified by ejection fraction (≤ 35% or > 35%), and the type of the index arrhythmia (VT - spontaneous or inducible by electrophysiologic study (EPS), versus other - VF, SCD, Primary prevention - MADIT II).
Ischemia severity was chosen to be evaluated by Single Photon Emission Computed Tomography (SPECT) during stress (dipyridamol infusion).
Subcutaneous adipose-tissue biopsy, a biomarker considered the gold-standard for the objective assessment of long-term habitual dietary intake of fish and marine omega-3 PUFA (EPA and DHA) will be obtain.
Compliance will be monitored by counting returned capsules or bottles and by measuring the omega-3 PUFA composition in red blood cells (RBC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •post-MI patients.
- •Both single and Dual chamber ICD recipient.
- •implanted more than 3 months ago.
- •Agree to give written informed consent.
排除标准
- •Less than 18 years of age.
- •ICD implantation as a 'bridge' to heart transplantation.
- •Stable antiarrhythmic medication over the last month prior to enrollment.
- •Patients taking class I antiarrhythmic medication.
- •A projected lifespan less than one year.
- •Participation in another trial (during or within 90 days before the study).
- •Use of supplemental n-3 fatty acids during the last 3 months.
- •Women who are pregnant and of childbearing potential who do not use adequate contraception.
- •Patients known to have a history of recent drug or alcohol abuse. 10) History or current intestinal or hepatic disease.
结局指标
主要结局
number of VT/VF episodes
时间窗: continous
次要结局
- All-cause mortality, cardiac mortality, recurrent and myocardial infarction.(continous)
- Atrial arrhythmia and non-sustained ventricular arrhythmia (non-sustained VT or ventricular premature complex (PVC)) as documented by ICD memory or 24 hour ECG (Holter) recording.(24 hours)
- Whether omega-3 PUFA supplementation exerts different effects according to ischemia severity assessed by stress perfusion nuclear imaging.(time of the test)