Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT00232232
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2005-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001282', 'term': 'Atrial Flutter'}], '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': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-08', 'studyFirstSubmitDate': '2005-10-02', 'studyFirstSubmitQcDate': '2005-10-02', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events related to fish oil ingestion.', 'timeFrame': '18 months', 'description': 'Tolerability, mortality.'}], 'primaryOutcomes': [{'measure': 'The extent of left atrial stunning in fish oil group compared to control after reversion of atrial arrhythmias to sinus rhythm.', 'timeFrame': '18 months'}]}, 'conditionsModule': {'keywords': ['Atrial mechanical stunning and', 'atrial electrical remodeling'], 'conditions': ['Atrial Fibrillation', 'Atrial Flutter']}, 'referencesModule': {'references': [{'pmid': '21232631', 'type': 'DERIVED', 'citation': 'Kumar S, Sutherland F, Wheeler M, Heck PM, Lee G, Teh AW, Garg ML, Morgan JG, Sparks PB. Effects of chronic omega-3 polyunsaturated fatty acid supplementation on human atrial mechanical function after reversion of atrial arrhythmias to sinus rhythm: reversal of tachycardia-mediated atrial cardiomyopathy with fish oils. Heart Rhythm. 2011 May;8(5):643-9. doi: 10.1016/j.hrthm.2011.01.014. Epub 2011 Jan 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether fish oils may be of benefit to patients with certain heart rhythm disturbances called atrial fibrillation and atrial flutter.\n\nAtrial fibrillation and atrial flutter are two heart conditions that can be successfully treated in the hospital by an ablation (in the case of atrial flutter) or a cardioversion (in the case of atrial fibrillation). Ablation involves the application of high frequency energy waves to a particular spot in the heart. Cardioversion involves resetting the heart back to a normal rhythm with the use of an electric current.\n\nFish oil supplements may be of benefit to patients with heart problems. Recent evidence suggests that fish oils may benefit those with rhythm disturbances.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic atrial flutter requiring radiofrequency ablation.\n* Chronic atrial fibrillation requiring internal cardioversion.\n\nExclusion Criteria:\n\n* Sinus rhythm.\n* Pregnancy.\n* Patients \\> 80 years and \\< 18 years of age'}, 'identificationModule': {'nctId': 'NCT00232232', 'briefTitle': 'Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia', 'organization': {'class': 'OTHER', 'fullName': 'Melbourne Health'}, 'orgStudyIdInfo': {'id': '2003.074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No fish oil'}, {'type': 'EXPERIMENTAL', 'label': 'Fish oil', 'description': 'Patients prescribed 6g/day of fish oil containing 1.8g EPA+DHA in a 1.5:1 ratio', 'interventionNames': ['Drug: Fish oil']}], 'interventions': [{'name': 'Fish oil', 'type': 'DRUG', 'armGroupLabels': ['Fish oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Paul Sparks', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Melbourne Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melbourne Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}