Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-30 @ 2:15 PM
Study NCT ID:
NCT05283603
Status:
RECRUITING
Last Update Posted:
2022-03-17
First Post:
2022-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Observational Registry of Patients With Left Bundle Branch Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002037', 'term': 'Bundle-Branch Block'}], 'ancestors': [{'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2029-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-12', 'studyFirstSubmitDate': '2022-02-25', 'studyFirstSubmitQcDate': '2022-03-12', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular dysfunction', 'timeFrame': '20 years', 'description': 'Echocardiographic left ventricular ejection fraction - EF (%)'}], 'secondaryOutcomes': [{'measure': 'Adverse cardiovascular events (e.g., heart failure)', 'timeFrame': '20 years', 'description': 'Heart failure (incidence and prevalence) Hospitalizations due to heart failure MACE'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Left Bundle Branch Block (LBBB) on ECG']}, 'referencesModule': {'references': [{'pmid': '34510787', 'type': 'BACKGROUND', 'citation': 'Sanna GD, De Bellis A, Zecchin M, Beccu E, Carta P, Moccia E, Canonico ME, Parodi G, Sinagra G, Merlo M. Prevalence, clinical and instrumental features of left bundle branch block-induced cardiomyopathy: the CLIMB registry. ESC Heart Fail. 2021 Dec;8(6):5589-5593. doi: 10.1002/ehf2.13568. Epub 2021 Sep 12.'}, {'pmid': '31186131', 'type': 'BACKGROUND', 'citation': 'Sanna GD, Merlo M, Moccia E, Fabris E, Masia SL, Finocchiaro G, Parodi G, Sinagra G. Left bundle branch block-induced cardiomyopathy: a diagnostic proposal for a poorly explored pathological entity. Int J Cardiol. 2020 Jan 15;299:199-205. doi: 10.1016/j.ijcard.2019.06.008. Epub 2019 Jun 4.'}, {'pmid': '31141243', 'type': 'BACKGROUND', 'citation': 'Moccia E, Sanna GD, Parodi G. Transient left bundle branch block and intraventricular dyssynchrony as a cause of reversible left ventricular dysfunction: The "in vivo" documentation of spontaneous electrical remodeling. Ann Noninvasive Electrocardiol. 2019 Nov;24(6):e12667. doi: 10.1111/anec.12667. Epub 2019 May 29.'}]}, 'descriptionModule': {'briefSummary': 'The electromechanical dyssynchrony induced by the presence of LBBB is in some patients, but not all, the cause of progressive left ventricular systolic dysfunction and heart failure.\n\nAims\n\n1. To investigate the clinical, ECG, imaging-derived features in a large cohort of patients affected by LBBB on ECG.\n2. To identify predictors of LBBB-induced LV systolic dysfunction and predictors of outcome in this population.\n3. To derive data which may have an impact on therapeutic management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with LBBB', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LBBB on ECG\n\nExclusion Criteria:\n\n* Previous extensive anterior myocardial infarction\n* Previous cardiac surgery or transcatheter aortic valve implantation (TAVI)\n* Congenital structural heart disease\n* Patients implanted with permanent right ventricular stimulation devices and permanent pacing\n* Denial to consent'}, 'identificationModule': {'nctId': 'NCT05283603', 'acronym': 'RECOrd-LBBB', 'briefTitle': 'Clinical Observational Registry of Patients With Left Bundle Branch Block', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero Universitaria di Sassari'}, 'officialTitle': 'Registro Osservazionale Dei Pazienti Con Blocco Della Branca Sinistra', 'orgStudyIdInfo': {'id': 'PG/2019/8862'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ECG, Echocardiogram, Magnetic resonance', 'type': 'DIAGNOSTIC_TEST', 'description': 'Clinical and instrumental follow-up'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07100', 'city': 'Sassari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe D Sanna, MD PhD', 'role': 'CONTACT', 'email': 'giuseppe.sanna@aousassari.it', 'phone': '0039 2061561'}], 'facility': 'Cardiology, AOU Sassari', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}], 'centralContacts': [{'name': 'Giuseppe D Sanna, MD PhD', 'role': 'CONTACT', 'email': 'giuseppe.sanna@aousassari.it', 'phone': '+39 0792061561'}, {'name': 'Giuseppe D Sanna, MD PhD', 'role': 'CONTACT', 'phone': '+39 0792061561'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero Universitaria di Sassari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Giuseppe Damiano Sanna', 'investigatorAffiliation': 'Azienda Ospedaliero Universitaria di Sassari'}}}}