Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT00597220
Status:
UNKNOWN
Last Update Posted:
2011-06-22
First Post:
2008-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-21', 'studyFirstSubmitDate': '2008-01-08', 'studyFirstSubmitQcDate': '2008-01-16', 'lastUpdatePostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival free of atrial fibrillation', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Number of patients in sinus rhythm at the time of each study visit', 'timeFrame': '12 months'}, {'measure': 'Number of hospitalizations for CV reasons', 'timeFrame': '12 months'}, {'measure': 'Number of all-cause hospitalizations', 'timeFrame': '12 months'}, {'measure': 'Incidence of TE events', 'timeFrame': '12 months'}, {'measure': 'Number of patients who die or with non-fatal thromboembolic events', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '23265344', 'type': 'DERIVED', 'citation': 'Macchia A, Grancelli H, Varini S, Nul D, Laffaye N, Mariani J, Ferrante D, Badra R, Figal J, Ramos S, Tognoni G, Doval HC; GESICA Investigators. Omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: results of the FORWARD (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation) trial. J Am Coll Cardiol. 2013 Jan 29;61(4):463-468. doi: 10.1016/j.jacc.2012.11.021. Epub 2012 Dec 19.'}, {'pmid': '19249410', 'type': 'DERIVED', 'citation': 'Macchia A, Varini S, Grancelli H, Nul D, Laffaye N, Ferrante D, Tognoni G, Doval HC; FORomegaARD investigators. The rationale and design of the FORomegaARD Trial: A randomized, double-blind, placebo-controlled, independent study to test the efficacy of n-3 PUFA for the maintenance of normal sinus rhythm in patients with previous atrial fibrillation. Am Heart J. 2009 Mar;157(3):423-7. doi: 10.1016/j.ahj.2008.10.027. Epub 2009 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate that in patients with persistent atrial fibrillation who had recovered normal sinus rhythm and treated with the best recommended therapies, the addition of 1 gram / daily of n-3 PUFA is superior to the corresponding placebo for the maintenance of normal sinus rhythm at one year of follow up.', 'detailedDescription': 'Atrial fibrillation (AF) impose a substantial and growing economic burden on health care expenditures. In patients with persistent AF, there are fundamentally two ways to manage the arrhythmia: to restore and maintain sinus rhythm (rhythm control) or to allow AF to continue and ensure that the ventricular rate is controlled (rate control). As it has been stated, it goes without saying that if we could prevent atrial fibrillation (AF) or restore and maintain sinus rhythm in patients suffering from persistent AF, without any penalties due to the unwanted effects of drugs or incomplete suppression of AF and its thromboembolic complications, every physician would do so. Current strategies however, are limited to achieve such desirable goal. In the last years a growing amount of evidence and attention regarding the cardio-protective role of Omega 3 fatty acids (n-3 PUFA) became progressively clear and appealing.\n\nEpidemiological studies and randomized controlled trials confirms the role of n-3 PUFA in reducing all cause mortality and cardiovascular events mostly in patients at high cardiovascular risk. These effects seems to be mediated mostly by an anti-arrhythmogenic effect.\n\nBasic science confirms and extended clinical observations regarding the antiarrhythmogenic effect of these compounds. Recently both basic research and clinical science suggested a role of n-3 PUFA for the prevention and treatment of supraventricular arrhythmias, particularly AF.\n\nThe purpose of the study is to show that the addition of n-3 PUFA on the top of the best recommended therapies can improve the maintenance of normal sinus rhythm in patients with persistent atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persistent atrial fibrillation\n\nExclusion Criteria:\n\n* Contraindications or known hypersensitivity to n-3 PUFA\n* Current treatment with n-3 PUFA for any reason\n* Heart failure NYHA class IV\n* Coronary artery bypass surgery or valve replacement within the past 3 months\n* Planned cardiac procedures\n* Known sick-sinus syndrome\n* Diagnosis of Wolff-Parkinson-White\n* Clinical significant valvular etiologies\n* Presence of arrhythmia associated with an acute reversible condition\n* Advanced chronic lung disease\n* Contraindications for anticoagulation therapy\n* Pregnancy or lactation\n* Any non cardiac illness associated with a life expectancy of \\< 2 years\n* Treatment with any investigational agent within 3 month before randomization\n* Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol'}, 'identificationModule': {'nctId': 'NCT00597220', 'acronym': 'FORWARD', 'briefTitle': 'Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion GESICA'}, 'officialTitle': 'Randomized, Prospective, Placebo-controlled, Multi-center Study to Test the Efficacy of n-3 PUFA for the Maintenance of Normal Sinus Rhythm in Patients With Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'FORWARD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Omega 3', 'interventionNames': ['Dietary Supplement: Omega 3 (n-3 PUFA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Omega 3 (n-3 PUFA)', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 gram of n-3 PUFA containing DHA and EPA', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1118', 'city': 'Caba', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Alemán'}, {'city': 'Caba', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Clinica Constituyentes'}, {'city': 'Caba', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Complejo Medico Policial Churruca Visca'}, {'city': 'Caba', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundacion Favaloro'}, {'city': 'Lanús', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Evita Pueblo FEDITEC', 'geoPoint': {'lat': -34.70757, 'lon': -58.39132}}, {'city': 'Mar del Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Clinica y Maternidad Colon', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'city': 'Mar del Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Privado de la Comunidad', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'city': 'Corrientes', 'state': 'Corrientes Province', 'country': 'Argentina', 'facility': 'Hospital José de San Martín', 'geoPoint': {'lat': -27.46784, 'lon': -58.8344}}, {'city': 'Córdoba', 'state': 'Córdoba Province', 'country': 'Argentina', 'facility': 'Clinica Romagosa', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'Misiones', 'state': 'Misiones Province', 'country': 'Argentina', 'facility': 'Sanatorio Integral IOT'}, {'city': 'Salta', 'state': 'Salta Province', 'country': 'Argentina', 'facility': 'Centro Cardiovascular Salta', 'geoPoint': {'lat': -24.80645, 'lon': -65.41999}}, {'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Sanatorio Parque', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'CEMIC (Centro de Educación Médica e Investigaciones Clinicas Norberto Quirno)', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Hernan C Doval, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fundacion GESICA'}, {'name': 'Gianni Tognoni, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mario Negri Institute'}, {'name': 'Hugo Grancelli, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundacion GESICA'}, {'name': 'Sergio Varini, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundacion GESICA'}, {'name': 'Daniel Nul, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundacion GESICA'}, {'name': 'Alejandro Macchia, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundacion GESICA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion GESICA', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Alejandro Macchia', 'oldOrganization': 'Fundacion GESICA'}}}}