Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT05283759
Status:
RECRUITING
Last Update Posted:
2022-03-17
First Post:
2022-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UZ Brussel HRMC Registry of Brugada Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053840', 'term': 'Brugada Syndrome'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample for DNA analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '30 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '1992-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2032-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-12', 'studyFirstSubmitDate': '2022-02-23', 'studyFirstSubmitQcDate': '2022-03-12', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventricular arrhythmias', 'timeFrame': 'through study completion, an average of 10 year', 'description': 'Composite of: sudden cardiac death, aborted sudden cardiac death, ventricular fibrillation, sustained ventricular tachycardia, ICD appropriate therapy'}, {'measure': 'Atrial fibrillation', 'timeFrame': 'through study completion, an average of 10 year', 'description': 'Atrial fibrillation occurrence'}, {'measure': 'Death for any cause', 'timeFrame': 'through study completion, an average of 10 year', 'description': 'Death for any cause'}, {'measure': 'Cardiovascular death', 'timeFrame': 'through study completion, an average of 10 year', 'description': 'Death for cardiovascular cause'}, {'measure': 'Genetic mutations', 'timeFrame': 'Baseline', 'description': 'Genetic mutations (pathogenic and variant of unknown significance) associated with Brugada syndrome. Wide gene panel with next generation sequencing will be used: Roche SeqCap® EZ Human Exome Probes v3.0 for BrS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brugada Syndrome']}, 'descriptionModule': {'briefSummary': 'The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome at UZ Brussel hospital (UZB).', 'detailedDescription': 'The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome.\n\nThese includes:\n\n1. demographical data: age, sex\n2. antropometric data: height, weight, BMI\n3. clinical data: comorbidities, arrhythmias, PM or ICD implantation, therapy\n\n3\\) data on the families: number of family members, sudden death history. 4) data on the genetics 5) data on: ECG, echocardiography, CT scan, MRI of heart, MRI of brain, ECG imaging, 3D electroanatomical mapping and ablation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Brugada syndrome patients diagnosed following current guidelines: (Priori SG, Blomstrom-Lundqvist C, Mazzanti A, et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death the Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC) Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J 2015;36:2793-2867.) Both Brugada spontaneous type 1 and ajmaline induced will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Brugada syndrome diagnosis\n\nExclusion Criteria:\n\n* Other diagnosis different from Brugada syndrome'}, 'identificationModule': {'nctId': 'NCT05283759', 'acronym': 'HRMCBrS', 'briefTitle': 'UZ Brussel HRMC Registry of Brugada Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'UZ Brussel Heart Rhythm Management Center Monocentric Registry of Brugada Syndrome', 'orgStudyIdInfo': {'id': 'UZ Brussel Brugada registry'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention because it is a patient registry', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Carlo de Asmundis, MD, PhD', 'role': 'CONTACT', 'email': 'hrmc@uzbrussel.be', 'phone': '+32024763704'}], 'facility': 'UZ Brussel Heart Rhythm Management Center', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Carlo de Asmundis, MD, PhD', 'role': 'CONTACT', 'email': 'hrmc@uzbrussel.be', 'phone': '+32024763704'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Heart Rhythm Management Center', 'investigatorFullName': 'Carlo de Asmundis', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}