Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet

December 11, 2006 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angouleme, France, 16470
        • Girac Hospital
      • Bordeaux, France, 33604
        • Hopital Du Haut-Leveque
      • Libourne, France, 33500
        • Robert Boulin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rate of recurrence on periods
Length of time to first recurrence of atrial fibrillation

Secondary Outcome Measures

Outcome Measure
subgroup analysis (high blood pressure, non persistent atrial fibrillation)
comparison between late and early recurrence (before or after 14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Jean-Paul Broustet, MD, PhD, Universitary Hospital Haut-Lévêque Bordeaux France
  • Study Chair: Serge C Renaud, VMD, PhD, Bordeaux2 University
  • Study Director: Dominique Lanzmann-Petithory, MD, PhD, Bordeaux2 University - Paris AP Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1999

Study Completion

June 1, 2003

Study Registration Dates

First Submitted

December 11, 2006

First Submitted That Met QC Criteria

December 11, 2006

First Posted (Estimate)

December 12, 2006

Study Record Updates

Last Update Posted (Estimate)

December 12, 2006

Last Update Submitted That Met QC Criteria

December 11, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGS 990321
  • 99-04 (CPPRB BORDEAUX B)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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