Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-03-02 @ 3:48 PM
Study NCT ID:
NCT00534300
Status:
COMPLETED
Last Update Posted:
2015-04-16
First Post:
2007-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous n-3 Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)-Pacemaker
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568345', 'term': 'fish oil triglycerides'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-15', 'studyFirstSubmitDate': '2007-09-21', 'studyFirstSubmitQcDate': '2007-09-21', 'lastUpdatePostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inducibility of ventricular tachycardia', 'timeFrame': 'Hours'}], 'secondaryOutcomes': [{'measure': 'Heart rate variability', 'timeFrame': 'Hours'}, {'measure': 'Ventricular repolarization parameters', 'timeFrame': 'Hours'}, {'measure': 'Concentration of n-3 fatty acids in plasma and platelet membranes', 'timeFrame': 'Hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ICD-pacemaker'], 'conditions': ['Ventricular Tachycardia', 'Sudden Cardiac Death']}, 'descriptionModule': {'briefSummary': 'The long-chain n-3 polyunsaturated fatty acids (PUFA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), appear to offer protection against sudden cardiac death and ventricular arrhythmias. EPA and DHA are essential fatty acids which are incorporated into cellular membranes after regular ingestion of fatty fish or fish oil.\n\nThis study investigates a possible acute effect of intravenous infusion of n-3 PUFA on inducibility of ventricular tachycardia (VT) in patients with an ICD-pacemaker.\n\nThe hypothesis is that an acute rise in the concentration of n-3 PUFA in plasma will increase the electric stability of the myocardial cells, so that VT is more difficult to induce.\n\nIn a randomized, placebo-controlled, double-blind, crossover study, a lipid emulsion with a high content of n-3 PUFA (or placebo: isotonic saline) will be administered intravenously before a non-invasive electrophysiologic examination performed via the ICD and following a predefined protocol.\n\nThe main outcome is inducibility of VT. If sustained VT is induced in a patient after both n-3 PUFA and placebo, the strength of the required stimulus after n-3 PUFA and after placebo is compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sustained ventricular tachycardia (VT) inducible during primary electrophysiological study (before ICD implantation) and one of the following\n\n * Latest VT episode terminated by anti-tachycardia pacing (ATP)\n * VT induced during primary electrophysiological study terminated by ATP\n\nExclusion Criteria:\n\n* Premenopausal women\n* Allergy to fish or egg protein\n* Blood pressure \\> 160/90 (treated or untreated)\n* MI, PCI or CABG within the previous 6 months\n* HbA1c \\> 10%\n* ALT \\> 150 U/L\n* INR \\> 3.5\n* Plasma-potassium \\< 3.5 mmol/L\n* Fasting triglycerides \\> 3 mmol/L\n* Other serious illness\n* Inability to sign informed consent'}, 'identificationModule': {'nctId': 'NCT00534300', 'briefTitle': 'Intravenous n-3 Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)-Pacemaker', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Intravenous Infusion of n-3 Polyunsaturated Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)', 'orgStudyIdInfo': {'id': 'IVN3ICD'}, 'secondaryIdInfos': [{'id': 'EudraCT number: 2005-002386-37'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: Omegaven']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: Isotonic saline']}], 'interventions': [{'name': 'Omegaven', 'type': 'DRUG', 'description': 'Lipid emulsion (omegaven) for intravenous use, 100 ml (25 mL/h)', 'armGroupLabels': ['A']}, {'name': 'Isotonic saline', 'type': 'DRUG', 'description': 'Intravenous infusion, 100 mL, 25mL/h', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Department of Cardiology, Aalborg Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Trine Madsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg Hospital, Aarhus University Hospital, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Trine Madsen', 'oldOrganization': 'Aalborg Hospital'}}}}