Studies of the Prevention of Atrial Fibrillation by ALA
Prevention of Atrial Fibrillation Recurrence By An Alpha-Linolenic Enriched Diet - A Pilot Study
研究概览
详细说明
Objective: We determined 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 successive patients successfully underwent electro cardioversion of whom 75 completed the study without major deviations according to the protocol.
Intervention: A canola margarine and oil together with a Mediterranean diet (ALA ω-3, 1.4 g/d) versus a conventional diet (control), with a one year follow-up.
Main outcome measure: Length of time to first recurrence of atrial fibrillation.
Significance: If ALA is antiarrhythmic this action may explain its cardioprotective effect in clinical trials and cohort studies.
研究类型
注册
阶段
- 阶段2
联系人和位置
学习地点
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Paris、法国、94456
- Emile Roux Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients hospitalized in one of the three centers in the Bordeaux region, and who subsequently underwent successful electrocardioversion for atrial fibrillation.
Exclusion Criteria:
- included patients who were unable to receive electrocardioversion or those who were already enrolled in another trial
- patients who were unable or unwilling to comply with the diet recommendations (experimental or control) or follow-up requirements
- patients with clinically significant cardiac disease, advanced heart failure, cardiac cachexia, thyroid disease, treated or untreated, clinically significant hepatic or renal disease or a history of malignant disease or alcohol abuse were not included
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
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rate of recurrence and length of time to first recurrence of atrial fibrillation.
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合作者和调查者
调查人员
- 首席研究员：Serge Renaud, MD, PhD、Emile Roux Hospital, A.P.H. Paris, 94456 Limeil-Brevannes, France
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
ALA rich diet的临床试验
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National Institute of Diabetes and Digestive and...完全的
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National Center for Research Resources (NCRR)Juvenile Diabetes Research Foundation未知
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Yale UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Juvenile Diabetes...完全的
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National Institute of Allergy and Infectious Diseases...Immune Tolerance Network (ITN)终止