Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:52 PM
Study NCT ID:
NCT00352560
Status:
COMPLETED
Last Update Posted:
2010-02-17
First Post:
2006-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)
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': 'D000077405', 'term': 'Irbesartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'dispFirstSubmitDate': '2010-02-15', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-15', 'studyFirstSubmitDate': '2006-07-12', 'dispFirstSubmitQcDate': '2010-02-15', 'studyFirstSubmitQcDate': '2006-07-13', 'dispFirstPostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients.', 'timeFrame': 'The measures are taken after 31 days of irbesartan treatment'}], 'secondaryOutcomes': [{'measure': 'Irbesartan effect on A Function RP', 'timeFrame': 'The measures are taken after 31 days of irbesartan treatment'}, {'measure': 'Irbesartan effect on atrial conduction intervals after basal & extra-stimuli, in PAF patients', 'timeFrame': 'The measures are taken after 31 days of irbesartan treatment'}, {'measure': 'Refractoriness dispersion', 'timeFrame': 'The measures are taken after 31 days of irbesartan treatment'}]}, 'conditionsModule': {'keywords': ['Patients with Paroxysmal Atrial Fibrillation (PAF)'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The main purpose of the study is to compare the mean AERP between treatment groups based on the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent PAF with indication for catheter ablation\n\nExclusion Criteria:\n\n* Struct. Cardiopathy\n* Mitral valve disease\n* VEF\\<40%\n* Myocardiopathy\n* LVH\n* cardiac surgery\n* AF reversible\n* QT c\\>450\n* Recent MI/stroke, severe HTN\n* Requirement of ACEI/ARBs\n* Coronary synd., HTA, liver disease'}, 'identificationModule': {'nctId': 'NCT00352560', 'briefTitle': 'Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)', 'orgStudyIdInfo': {'id': 'CV131-235'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: Irbesartan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Irbesartan', 'type': 'DRUG', 'otherNames': ['Avapro'], 'description': 'Tablets, Oral, 300 mg, once daily, 30 days.', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, Oral, 0 mg, once daily, 30 days.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28905', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Miguel Angel Sanchez Zamorano, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Department, Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}]}}}