Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-02 @ 8:23 AM
Study NCT ID:
NCT05508932
Status:
RECRUITING
Last Update Posted:
2025-07-25
First Post:
2022-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Fibrillation in Beta-Thalassemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D013789', 'term': 'Thalassemia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2032-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2022-08-16', 'studyFirstSubmitQcDate': '2022-08-18', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial fibrillation', 'timeFrame': '10 years', 'description': 'New onset of Atrial Fibrillation documented at ECG'}], 'secondaryOutcomes': [{'measure': 'Thromboembolism', 'timeFrame': '10 years', 'description': 'Stroke or peripheral embolization'}, {'measure': 'Epicardial adipose tissue', 'timeFrame': 'Baseline', 'description': 'Thickness of fat depot in epicardial region'}, {'measure': 'SGLT2 effect on Hb', 'timeFrame': '6 months', 'description': 'rise in hemoblogin levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Thalassemia', 'Thalassaemia', 'Arrhythmia', 'Hemoglobinopathies'], 'conditions': ['Atrial Fibrillation', 'Thalassemia']}, 'referencesModule': {'references': [{'pmid': '41065927', 'type': 'DERIVED', 'citation': 'Malagu M, Marchini F, Longo F, Zuin M, Orazio G, Capanni A, Berloni ML, Frascaro F, Tonet E, Cossu A, Culcasi M, Bonsi B, Balla C, Vitali F, Bertini M. Association between epicardial adipose tissue and transfusion-dependent beta-thalassemia. Int J Cardiovasc Imaging. 2025 Nov;41(11):2255-2263. doi: 10.1007/s10554-025-03535-2. Epub 2025 Oct 9.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the clinical, laboratory and instrumental differences that exist between beta-thalassemia patients with atrial fibrillation and those not affected by arrhythmia.', 'detailedDescription': 'Observational, retrospective and prospective, single-center study, which involves the collection of clinical, laboratory, electrocardiographic and imaging data of patients with major or intermediate thalassemia who have performed, from 2012 to 2022, or will perform in the next 10 years, a cardiological evaluation at the Cardiology Unit of the University Hospital of Ferrara. Patients will be divided into two groups: thalassemia patients with atrial fibrillation (paroxysmal, persistent or permanent) and thalassemia patients with no history of atrial fibrillation.\n\nThe objective of the study is to evaluate whether there is a different prevalence of the characteristics analyzed among these patient populations.\n\nAs secondary outcome, the effect of SGLT2-inhibitors (empaglifozin, dapaglifozin, ...) will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Transfusion-dependent Beta-thalassemia patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Transfusion-dependent Beta-thalassemia;\n2. Follow-Up at the Cardiology Unit of the University Hospital of Ferrara;\n3. Electrocardiogram performed;\n4. Echocardiogram performed.\n\nExclusion Criteria:\n\n1. Age \\<18 years;\n2. State Of pregnancy;\n3. Inability to give informed consent.'}, 'identificationModule': {'nctId': 'NCT05508932', 'briefTitle': 'Atrial Fibrillation in Beta-Thalassemia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Ferrara'}, 'officialTitle': 'Atrial Fibrillation in Beta-Thalassemia', 'orgStudyIdInfo': {'id': '419/2022/Oss/AOUFe'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Beta-thalassemia', 'description': 'Patients with Beta-thalassemia undergoing a cardiological evaluation'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ferrara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Matteo Bertini', 'role': 'CONTACT', 'email': 'brtmtt2@unife.it', 'phone': '+39 0532236269'}], 'facility': 'Matteo Bertini', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Ferrara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Matteo Bertini', 'investigatorAffiliation': 'University Hospital of Ferrara'}}}}