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Studies of the Prevention of Atrial Fibrillation by ALA

Primary Purpose

Atrial Fibrillation, Diet Therapy

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
ALA rich diet
Sponsored by
University of Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emile Roux Hospital

Outcomes

Primary Outcome Measures

rate of recurrence and length of time to first recurrence of atrial fibrillation.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2006
Last Updated
December 12, 2006
Sponsor
University of Toronto
Collaborators
University Hospital, Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT00410839
Brief Title
Studies of the Prevention of Atrial Fibrillation by ALA
Official Title
Prevention of Atrial Fibrillation Recurrence By An Alpha-Linolenic Enriched Diet - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2004
Overall Recruitment Status
Unknown status
Study Start Date
June 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Toronto
Collaborators
University Hospital, Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

5. Study Description

Brief Summary
An alpha-linolenic acid (ALA) rich diet in the Lyon 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 as a cardioprotective nutrient. Much of the interest has focused on the potential antiarrhythmic effect of ω-3 fatty acids, especially the longer chain ω-3 fatty acids, DHA and EPA, derived from fish. We therefore concluded it important to test whether the shorter chain ω-3 vegetable oil ALA also had antiarrhythmic effects, since this might also explain the beneficial effects seen on cardiovascular mortality in the Lyon Heart Study.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Diet Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
ALA rich diet
Primary Outcome Measure Information:
Title
rate of recurrence and length of time to first recurrence of atrial fibrillation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge Renaud, MD, PhD
Organizational Affiliation
Emile Roux Hospital, A.P.H. Paris, 94456 Limeil-Brevannes, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emile Roux Hospital
City
Paris
ZIP/Postal Code
94456
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
7911176
Citation
de Lorgeril M, Renaud S, Mamelle N, Salen P, Martin JL, Monjaud I, Guidollet J, Touboul P, Delaye J. Mediterranean alpha-linolenic acid-rich diet in secondary prevention of coronary heart disease. Lancet. 1994 Jun 11;343(8911):1454-9. doi: 10.1016/s0140-6736(94)92580-1. Erratum In: Lancet 1995 Mar 18;345(8951):738.
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Studies of the Prevention of Atrial Fibrillation by ALA

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