Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-30 @ 11:52 PM
Study NCT ID:
NCT06556732
Status:
RECRUITING
Last Update Posted:
2024-08-16
First Post:
2024-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patients With Structural Heart Disease
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': 'D000638', 'term': 'Amiodarone'}], 'ancestors': [{'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2024-08-12', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AF recurrence', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a prospective comparative study, conducted at Cardiology Department, Aswan University Hospital on AF patients with structural heart disease. Eplerenone 25 mg daily will be given and searching for AF recurrence among study population.', 'detailedDescription': 'This is a prospective comparative study, conducted at Cardiology Department, Aswan University Hospital, on 100 patients with AF and structural heart disease. AF is confirmed by electrocardiography. The patients were divided into 2 groups:\n\nGroup A (study group): 50 patients received eplerenon 25 mg daily plus amiodarone and other medications not including non-dihydropyridine calcium channel blocker or digoxin.\n\nGroup B (control group): 50 patients received amiodarone and other medications not including non-dihydropyridine calcium channel blocker or digoxin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with non-valvular AF who underwent cardioversion to sinus rhythm either medical, electrical or even spontaneously\n\nExclusion Criteria:\n\n* Patients with rheumatic heart disease.\n* Thyroid dysfunction.\n* Wolf-Parkinson-White (WPW) syndrome.\n* Renal impairment.\n* Hyperkalemia.\n* Acute coronary syndrome.\n* Pregnancy.\n* Left ventricular (LV) dysfunction with ejection fraction (EF) less than 40%.\n* On current use of eplerenone.'}, 'identificationModule': {'nctId': 'NCT06556732', 'briefTitle': 'Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patients With Structural Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Potential Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patients With Structural Heart Disease', 'orgStudyIdInfo': {'id': 'Eplerenone in AF 2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study arm', 'description': 'Were given Eplereone 25 mg daily', 'interventionNames': ['Drug: Eplereone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm', 'description': 'Were given nothing', 'interventionNames': ['Drug: Eplereone']}], 'interventions': [{'name': 'Eplereone', 'type': 'DRUG', 'otherNames': ['Amiodarone'], 'description': 'Group A (study group): 50 patients received eplerenon 25 mg daily plus amiodarone and other medications not including non-dihydropyridine calcium channel blocker or digoxin.', 'armGroupLabels': ['Control arm', 'Study arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71526', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Abdel-Galeel, MD', 'role': 'CONTACT', 'email': 'ahmed.galeel@aun.edu.eg', 'phone': '+201005024562'}], 'facility': 'Assiut University Heart Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ahmed Abdelgaleel', 'investigatorAffiliation': 'Assiut University'}}}}