The Effect of Omega-3 Polyunsaturated Fatty Acid Supplements on Microvolt T Wave Alternans in Patients With Ventricular Arrhythmia
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in microvolt T wave alternans status
研究概览
简要总结
This is a hypothesis testing study, the hypothesis being that dietary supplements of n-PUFAs concentrates are anti-arrhythmic in ventricular arrhythmic substrates.
Study Aims: To investigate whether dietary supplements of n-3 polyunsaturated fatty acid concentrates (2g PUFAs/day, Omacor) reduces MTWA (a surrogate endpoint for ventricular arrhythmia substrate) in patients with ICDs for malignant ventricular arrhythmias.
详细描述
Patients from the Department of Cardiology ICD out-patient clinic, Ninewells Hospital and Medical School, will be recruited. All these patients have a history of documented ventricular arrhythmia. Data from previous studies predict that 90% of these patients will have abnormal MTWA. A total of 45 ICD patients will be recruited. The study design will be a double blind randomised placebo controlled crossover design. A baseline MTWA test will be performed and patients with an abnormal test will be selected. The patients will be randomised to receive fish oil supplements (2g/day) or placebo for 8 weeks each. At the end of each intervention period, a repeat MWTA test will be performed. A 10 ml venous blood sampled will also be collected at baseline, and after each intervention period (3 samples in total). Patients in atrial fibrillation, frequent atrial or ventricular ectopics, or with ventricular pacing from the ICD, unstable angina, NYHA IV heart failure, pregnancy or child bearing potential will be excluded from the study.
End Points of the Study. The primary endpoint will be quantitative and qualitative measures of MTWA during n-3 PUFAs treatment compared to placebo.
Statistical Analysis
Quantitative differences in MTWA measurements will be analysed by a Student's t-test and qualitative differences by a chi squared test. A probability of 0.05% will be considered significant.
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, Investigator)
入排标准
- 年龄范围
- 21 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •implantable cardiovertor defibrillators
- •microvolt Twave alternans positive
排除标准
- •unstable angina
结局指标
主要结局
Change in microvolt T wave alternans status
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
AChoy
Senior Clinical Lecturer and Honorary Consultant Cardiologist
University of Dundee
