Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT00647192
Status:
TERMINATED
Last Update Posted:
2012-02-10
First Post:
2008-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion
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': 'D000077545', 'term': 'Eplerenone'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': 'Inclusion rate too low. Recruitment of further study centers too costly.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-09', 'studyFirstSubmitDate': '2008-03-26', 'studyFirstSubmitQcDate': '2008-03-28', 'lastUpdatePostDateStruct': {'date': '2012-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Sinus rhythm within eplerenone treatment before planned electrical cardioversion', 'timeFrame': '3 weeks'}, {'measure': 'Cardioversion success', 'timeFrame': 'at least one sinus beat'}, {'measure': 'Time to recurrence of atrial fibrillation', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'electrical cardioversion', 'prevention of atrial fibrillation recurrence', 'mineralocorticoid receptor blocker', 'eplerenone', 'Recurrence of atrial fibrillation after cardioversion'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Eplerenone reduces atrial fibrillation (AF) recurrences within the first 8 weeks after electrical cardioversion of persistent AF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persistent atrial fibrillation (AF), AF persistence for \\> 7 days but \\< 1 year\n* Total AF history \\< 2 years\n* Written informed consent of the patient\n* Age ≥18 years\n* Female patients are sterilised or postmenopausal or apply an adequate method for contraception (Pearl index \\<1%) and have a negative pregnancy test (ß-HCG) and do not breastfeed/nurse.\n\nExclusion Criteria:\n\n* Hemodynamic instability or symptoms not allowing cardioversion to be delayed for 3 weeks\n* Myocardial infarction within the last 3 months\n* Heart failure NYHA class III - IV\n* Uncontrolled hypertension, defined as a systolic blood pressure \\> 160 mm Hg and/or a diastolic blood pressure \\> 95 mm Hg (anti-hypertensive treatment is allowed).\n* Pre-treatment with an aldosterone antagonist or other potassium sparing diuretics\n* Instable angina pectoris\n* Use of Digitalis\n* Use of class I or class III antiarrhythmic drugs (must be stopped at least 5 half-life before)\n* Contraindication or hypersensitivity to ß-blockers\n* Open heart surgery within the last 3 months\n* Pregnancy\n* Acute and reversible illnesses\n* Acute and chronic infection\n* Alcohol or drug abuse or a severe progressive extracardiac disease\n* Untreated manifest and latent hyper- or hypothyroidism or \\< 3 months peripheral euthyroidism (normal fT3)\n* Moderate to severe renal insufficiency (Creatinine clearance less than 50 ml/min)\n* Patients with liver cirrhosis (Child-Pugh class C)\n* Co-administration of strong CYP3A4 inhibitors (e.g. Itraconazole, Ketoconazole, Ritonavir, Nelfinavir, Clarithromycin, Telithromycin and Nephazodon)\n* Hypersensitivity against Eplerenone and/or one of the other components of the tablet (see Fachinformation)\n* Serum potassium \\> 5 mmol/l\n* Patients unlikely to comply with the protocol'}, 'identificationModule': {'nctId': 'NCT00647192', 'acronym': 'EPLERAF', 'briefTitle': 'EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Saarland'}, 'officialTitle': 'EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion', 'orgStudyIdInfo': {'id': 'EPLERAF-01'}, 'secondaryIdInfos': [{'id': 'Version 09_D'}, {'id': 'EudraCT number: 2007-002119-17'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Eplerenone treatment', 'interventionNames': ['Drug: Eplerenone']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Eplerenone', 'type': 'DRUG', 'description': '50 mg per day', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '50 mg per day', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg/Saar', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III'}, {'zip': 'NL-9700 RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Rijksuniversiteit Groningen, Universitair Medisch Centrum', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Michael Böhm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Saarland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Medical Center Groningen', 'class': 'OTHER'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}