Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-21 @ 4:37 AM
Study NCT ID:
NCT01233635
Status:
TERMINATED
Last Update Posted:
2023-03-23
First Post:
2010-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}}, 'statusModule': {'whyStopped': 'inadequate enrollment rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2010-11-02', 'studyFirstSubmitQcDate': '2010-11-02', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AF burden', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'In the present application, we propose to refine and extend current insight into AAF mechanism and therapy by examining the importance of pharmacologic RAAS inhibition, ACE genotype, and their interaction in secondary AF prevention. We have 3 specific aims:\n\n1. To confirm that RAAS inhibition therapy reduces the incidence of AF recurrence.\n2. To test the hypothesis that the incidence of AF recurrence in the absence of RAAS inhibition therapy is higher among patients with the D allele.\n3. To explore the hypothesis that RAAS inhibition therapy is more effective for preventing AF recurrence in patients with the DD genotype than in those with DI or II genotypes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be in atrial fibrillation confirmed by 12 lead EKG.\n* blood pressure \\> 90 mmHg\n* Patient without cardiopulmonary symptoms\n* 18+ years of age\n\nExclusion Criteria:\n\n* Contraindiction to warfarin\n* Recent (within 6 months) MI or cardiac revascularization\n* Recent (within 6 months) CVA or TIA\n* NYHA Class IV CHF\n* Active thyroid disease\n* Major hepatic dysfunction\n* Renal dysfunction (\\>2 mg/dL)\n* Hyperkalemia (\\>4.6 mEq/L)\n* Hyponatremia (\\<130 mEq/L)\n* Currently taking a Vaughn-Williams Type I or III antiarrhythmic drug\n* History of ARB intolerance\n* Contraindication to ARB therapy\n* Pregnancy\n* Female of childbearing age\n* Age \\< 18 years of age\n* Inability to give informed consent\n* Other medical conditions calling 1 year survival into question'}, 'identificationModule': {'nctId': 'NCT01233635', 'briefTitle': 'Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)', 'orgStudyIdInfo': {'id': '0507061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A Group 1 no drug', 'description': 'Patients who have not taken ACE/ARB, randomized to no drug.', 'interventionNames': ['Other: no drug']}, {'type': 'EXPERIMENTAL', 'label': 'A Group 2', 'description': 'Patients who have not taken ACE/ARB, randomized to take cozaar.', 'interventionNames': ['Drug: start cozaar']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Patients currently taking ACE/ARB will have their prescription changed to cozaar.', 'interventionNames': ['Drug: continue cozaar']}], 'interventions': [{'name': 'no drug', 'type': 'OTHER', 'description': 'none, no drug', 'armGroupLabels': ['A Group 1 no drug']}, {'name': 'start cozaar', 'type': 'DRUG', 'description': 'start cozaar', 'armGroupLabels': ['A Group 2']}, {'name': 'continue cozaar', 'type': 'DRUG', 'description': 'continue cozaar', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC CVI', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}