Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT00410020
Status:
COMPLETED
Last Update Posted:
2006-12-12
First Post:
2006-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'completionDateStruct': {'date': '2003-06'}, 'lastUpdateSubmitDate': '2006-12-11', 'studyFirstSubmitDate': '2006-12-11', 'studyFirstSubmitQcDate': '2006-12-11', 'lastUpdatePostDateStruct': {'date': '2006-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of recurrence on periods'}, {'measure': 'Length of time to first recurrence of atrial fibrillation'}], 'secondaryOutcomes': [{'measure': 'subgroup analysis (high blood pressure, non persistent atrial fibrillation)'}, {'measure': 'comparison between late and early recurrence (before or after 14 days)'}]}, 'conditionsModule': {'keywords': ['alpha linolenic acid', 'atrial fibrillation', 'omega 3 fatty acids', 'diet', 'rapeseed oil', 'canola oil', 'cardiovascular diseases'], 'conditions': ['Atrial Fibrillation', 'Diet Therapy']}, 'referencesModule': {'references': [{'pmid': '7911176', 'type': 'BACKGROUND', '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.'}, {'pmid': '7754988', 'type': 'BACKGROUND', 'citation': 'Renaud S, de Lorgeril M, Delaye J, Guidollet J, Jacquard F, Mamelle N, Martin JL, Monjaud I, Salen P, Toubol P. Cretan Mediterranean diet for prevention of coronary heart disease. Am J Clin Nutr. 1995 Jun;61(6 Suppl):1360S-1367S. doi: 10.1093/ajcn/61.6.1360S.'}, {'pmid': '6133188', 'type': 'BACKGROUND', 'citation': 'Renaud S, Nordoy A. "Small is beautiful": alpha-linolenic acid and eicosapentaenoic acid in man. Lancet. 1983 May 21;1(8334):1169. doi: 10.1016/s0140-6736(83)92902-1. No abstract available.'}, {'pmid': '12450919', 'type': 'BACKGROUND', 'citation': 'Lanzmann-Petithory D, Pueyo S, Renaud S. Primary prevention of cardiovascular diseases by alpha-linolenic acid. Am J Clin Nutr. 2002 Dec;76(6):1456; author reply 1456-7. doi: 10.1093/ajcn/76.6.1456. No abstract available.'}, {'pmid': '11935975', 'type': 'BACKGROUND', 'citation': 'Renaud SC, Lanzmann-Petithory D. alpha-linolenic acid in the prevention of cardiovascular diseases. World Rev Nutr Diet. 2001;88:79-85. doi: 10.1159/000059769. No abstract available.'}, {'pmid': '12324307', 'type': 'BACKGROUND', 'citation': 'Renaud SC, Lanzmann-Petithory D. The beneficial effect of alpha-linolenic acid in coronary artery disease is not questionable. Am J Clin Nutr. 2002 Oct;76(4):903-4; author reply 904-6. doi: 10.1093/ajcn/76.4.903. No abstract available.'}, {'pmid': '12433513', 'type': 'BACKGROUND', 'citation': 'Singh RB, Dubnov G, Niaz MA, Ghosh S, Singh R, Rastogi SS, Manor O, Pella D, Berry EM. Effect of an Indo-Mediterranean diet on progression of coronary artery disease in high risk patients (Indo-Mediterranean Diet Heart Study): a randomised single-blind trial. Lancet. 2002 Nov 9;360(9344):1455-61. doi: 10.1016/S0140-6736(02)11472-3.'}, {'pmid': '11458289', 'type': 'BACKGROUND', 'citation': 'Lanzmann-Petithory D. Alpha-linolenic acid and cardiovascular diseases. J Nutr Health Aging. 2001;5(3):179-83.'}, {'pmid': '8851173', 'type': 'BACKGROUND', 'citation': 'Kang JX, Leaf A. Protective effects of free polyunsaturated fatty acids on arrhythmias induced by lysophosphatidylcholine or palmitoylcarnitine in neonatal rat cardiac myocytes. Eur J Pharmacol. 1996 Feb 15;297(1-2):97-106. doi: 10.1016/0014-2999(95)00701-6.'}, {'pmid': '7722678', 'type': 'BACKGROUND', 'citation': 'McLennan PL, Dallimore JA. Dietary canola oil modifies myocardial fatty acids and inhibits cardiac arrhythmias in rats. J Nutr. 1995 Apr;125(4):1003-9. doi: 10.1093/jn/125.4.1003.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nSince 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.\n\nWe 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.', 'detailedDescription': 'Objective: To determine the effect of an ALA rich diet in reducing recurrence of atrial fibrillation as a further example of a cardiac arrhythmia.\n\nDesign: Randomized parallel design efficacy study.\n\nSetting: Three university hospital centers in the Bordeaux region, France.\n\nPatients: 98 patients randomized immediately after successful atrial fibrillation electrical cardioversion.\n\nIntervention: A canola margarine and oil, versus a conventional diet (control), with a one year follow-up.\n\nMain outcome measure: Length of time to first recurrence of atrial fibrillation.\n\nSignificance: If ALA is antiarrhythmic, this action may explain its cardioprotective effect in clinical trials and cohort studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients hospitalized in one of the three centers in the Bordeaux region\n* clinical diagnosis of atrial fibrillation\n* who subsequently underwent successful electrical cardioversion\n\nExclusion Criteria:\n\n* unable to receive electrical cardioversion\n* already enrolled in another trial\n* unable or unwilling to comply with the diet recommendations (experimental or control) or follow-up requirements\n* clinically significant cardiac disease, advanced heart failure, cardiac cachexia\n* thyroid disease, treated or untreated,\n* clinically significant hepatic or renal disease\n* history of malignant disease\n* alcohol abuse\n* 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'}, 'identificationModule': {'nctId': 'NCT00410020', 'briefTitle': 'Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Secondary Prevention of Atrial Fibrillation With an Alpha-Linolenic Enriched Diet : a Randomized Study', 'orgStudyIdInfo': {'id': 'DGS 990321'}, 'secondaryIdInfos': [{'id': '99-04 (CPPRB BORDEAUX B)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Alpha-linolenic enriched diet', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16470', 'city': 'Angoulême', 'country': 'France', 'facility': 'Girac Hospital', 'geoPoint': {'lat': 45.64997, 'lon': 0.15345}}, {'zip': '33604', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital du Haut-Lévêque', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33500', 'city': 'Libourne', 'country': 'France', 'facility': 'Robert Boulin Hospital', 'geoPoint': {'lat': 44.91449, 'lon': -0.24186}}], 'overallOfficials': [{'name': 'Jean-Paul Broustet, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitary Hospital Haut-Lévêque Bordeaux France'}, {'name': 'Serge C Renaud, VMD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bordeaux2 University'}, {'name': 'Dominique Lanzmann-Petithory, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bordeaux2 University - Paris AP Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}]}}}