Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT00692718
Status:
UNKNOWN
Last Update Posted:
2008-06-19
First Post:
2008-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
N-3 Fatty Acids for the Prevention of Atrial Fibrillation in Patients With Acute Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C035276', 'term': 'eicosapentaenoic acid ethyl ester'}, {'id': 'D015118', 'term': 'Eicosapentaenoic Acid'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'lastUpdateSubmitDate': '2008-06-18', 'studyFirstSubmitDate': '2008-05-29', 'studyFirstSubmitQcDate': '2008-06-04', 'lastUpdatePostDateStruct': {'date': '2008-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'detection of atrial fibrillation on ECG monitoring', 'timeFrame': 'anytime during hospitalization'}]}, 'conditionsModule': {'conditions': ['Acute Heart Failure', 'Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Our study is to investigate the effect of N-3 Fatty Acids for the prevention of atrial fibrillation in patients with acute heart failure or acute myocardial infarction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sinus rhythm patients with acute heart failure or acute myocardial infarction\n\nExclusion Criteria:\n\n* pregnancy,allergy to epadel'}, 'identificationModule': {'nctId': 'NCT00692718', 'briefTitle': 'N-3 Fatty Acids for the Prevention of Atrial Fibrillation in Patients With Acute Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Osaka General Medical Center'}, 'officialTitle': 'N-3 Fatty Acids for the Prevention of Atrial Fibrillation in Patients With Acute Heart Failure', 'orgStudyIdInfo': {'id': 'OFAHeft'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Epadel, Eicosapentaenoic acid', 'type': 'DRUG', 'description': 'Epadel 900mg, 2 times a day, during hospitalization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osaka General Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Masaharu Masuda', 'oldOrganization': 'Osaka Geneeal Medical Cener'}}}}