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NCT Number: NCT00410020

Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Diet Therapy Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Girac Hospital, Angoulême, France

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About this study

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients hospitalized in one of the three centers in the Bordeaux region
  • clinical diagnosis of atrial fibrillation
  • who subsequently underwent successful electrical cardioversion

Exclusion criteria

  • 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

Treatment and study plan

Alpha-linolenic enriched diet

Behavioral

Primary outcomes

  1. Rate of recurrence on periods

  2. Length of time to first recurrence of atrial fibrillation

Secondary outcomes

  1. subgroup analysis (high blood pressure, non persistent atrial fibrillation)

  2. comparison between late and early recurrence (before or after 14 days)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • University Hospital, Bordeaux

Registry information

Official study title

Secondary Prevention of Atrial Fibrillation With an Alpha-Linolenic Enriched Diet : a Randomized Study

Important dates

Study start
1999
Study completion
2003
First posted
Dec 12, 2006
Registry last updated
Dec 12, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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