Secondary Prevention of Atrial Fibrillation With an Alpha-Linolenic Enriched Diet : a Randomized Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 6
- 主要终点
- Rate of recurrence on periods
研究概览
简要总结
An alpha linolenic acid (ALA) rich diet in the Lyon Diet Heart Study reduced sudden cardiac deaths possibly by reducing cardiac arrhythmias and ventricular fibrillation (Lancet 1994).
Since then, there has been a growing interest in ALA, ω-3 fatty acid family precursor, as a cardioprotective nutrient. Much of the interest has focused on the potential antiarrhythmic effect of longer chain ω-3 fatty acids, DHA and EPA, derived from fish.
We therefore concluded it important to test wether vegetable source ω-3 also had antiarrhythmic effects, as shown in animals by Leaf and McLennan, since this might also explain the beneficial effects seen on cardiovascular mortality in the Lyon Diet Heart Study.
详细描述
Objective: To determine the effect of an ALA rich diet in reducing recurrence of atrial fibrillation as a further example of a cardiac arrhythmia.
Design: Randomized parallel design efficacy study.
Setting: Three university hospital centers in the Bordeaux region, France.
Patients: 98 patients randomized immediately after successful atrial fibrillation electrical cardioversion.
Intervention: A canola margarine and oil, versus a conventional diet (control), with a one year follow-up.
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
- None
入排标准
- 年龄范围
- 18 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients hospitalized in one of the three centers in the Bordeaux region
- •clinical diagnosis of atrial fibrillation
- •who subsequently underwent successful electrical cardioversion
排除标准
- •unable to receive electrical cardioversion
- •already enrolled in another trial
- •unable or unwilling to comply with the diet recommendations (experimental or control) or follow-up requirements
- •clinically significant cardiac disease, advanced heart failure, cardiac cachexia
- •thyroid disease, treated or untreated,
- •clinically significant hepatic or renal disease
- •history of malignant disease
- •alcohol abuse
- •taking ALA rich foods or recording intakes of ALA >2g/d on the control diet or reporting using <1g/d on the ALA diet was considered a major deviation from the protocol
结局指标
主要结局
Rate of recurrence on periods
Length of time to first recurrence of atrial fibrillation
次要结局
- subgroup analysis (high blood pressure, non persistent atrial fibrillation)
- comparison between late and early recurrence (before or after 14 days)