Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-11 @ 6:38 AM
Study NCT ID:
NCT05521451
Status:
RECRUITING
Last Update Posted:
2025-03-30
First Post:
2022-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Cohort Study - TRUST
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001282', 'term': 'Atrial Flutter'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D019571', 'term': 'Arrhythmogenic Right Ventricular Dysplasia'}, {'id': 'D008133', 'term': 'Long QT Syndrome'}, {'id': 'D053840', 'term': 'Brugada Syndrome'}, {'id': 'D013617', 'term': 'Tachycardia, Supraventricular'}, {'id': 'D000098850', 'term': 'Polymorphic Catecholaminergic Ventricular Tachycardia'}, {'id': 'D016171', 'term': 'Torsades de Pointes'}], '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': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sampling at baseline: Whole blood, serum, cellular RNA Collection of tissue samples excised in clinical routine (e. g. left atrial appendages after surgical closure)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2022-08-22', 'studyFirstSubmitQcDate': '2022-08-26', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to a composite of cardiovascular mortality, stroke, acute coronary syndrome and heart failure hospitalization', 'timeFrame': 'Follow-up 5 years after inclusion', 'description': "The main primary outcome measures the time until any of death from cardiovascular cause, stroke or TIA or a hospitalization due to heart failure or acute coronary syndrome occurs for the first time after inclusion. The outcome is measured via telephone and / or in-person follow-up, acquisition of all relevant medical records between inclusion and follow-up timepoint and a questionnaire sent to the patient. The follow-up can be completed fully electronically according to patient's wish."}, {'measure': 'New onset of cardiac arrhythmias, documented in clinical care and during systematic rhythm monitoring using digital devices.', 'timeFrame': 'Follow-up 5 years after inclusion', 'description': 'The outcome is measured via remote follow-up using consumer-electronics based remote rhythm monitoring technologies. Additionally, onset of new cardiac arrhythmias is assessed from medical records collected between follow-up timepoint and inclusion as well as questionnaires and a telephone call with the patient.'}], 'secondaryOutcomes': [{'measure': 'Time to recurrence of the clinical arrhythmia', 'timeFrame': 'Follow-up 5 years after inclusion', 'description': 'The outcome is measured via remote follow-up using consumer-electronics based remote rhythm monitoring technologies. Additionally, onset of new cardiac arrhythmias is assessed from medical records collected between follow-up timepoint and inclusion as well as questionnaires and a telephone call with the patient.'}, {'measure': 'New onset of heart failure', 'timeFrame': 'Follow-up 5 years after inclusion', 'description': 'This endpoint is defined as a new diagnosis of heart failure with (milly) reduced or preserved ejection fraction according to ESC guidelines. The patients medical record will be reassessed at the end of follow-up.'}, {'measure': 'All-cause mortality (Safety Outcome)', 'timeFrame': 'Follow-up 5 years after inclusion', 'description': 'This endpoint is assessed during the telephone call during remote follow-up and - if not applicable - via consultation of the death registry.'}, {'measure': 'Patient reported quality of life (QOL)', 'timeFrame': 'Follow-up 5 years after inclusion', 'description': 'As assessed via AF Effect on QualiTy of life survey at the timepoint of follow-up.'}, {'measure': 'Health care utilisation', 'timeFrame': 'Follow-up 5 years after inclusion', 'description': 'Health care utilisation after inclusion is assessed during the telephone call of the remote follow-up as well as via acquisition of all medical records between follow-up timepoint and inclusion.'}, {'measure': 'Complications of rhythm control therapy (Safety Outcome)', 'timeFrame': 'Follow-up 5 years after inclusion', 'description': 'This endpoint is assessed during the telephone call of the remote follow-up as well as via acquisition of all medical records between follow-up timepoint and inclusion.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Catheter Ablation', 'Biomarkers', 'Cardiac Arrhythmia', 'eHealth', 'Digital Cardiology', 'Echocardiography', 'Atrial Cardiomyopathy'], 'conditions': ['Arrhythmias, Cardiac', 'Atrial Fibrillation', 'Atrial Flutter', 'Ventricular Tachycardia', 'Atrial Tachycardia', 'Arrhythmogenic Right Ventricular Dysplasia', 'Long QT Syndrome', 'Brugada Syndrome', 'Supraventricular Tachycardia', 'Catecholaminergic Polymorphic Ventricular Tachycardia', 'Torsades De Pointes', 'Atrial Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '40810874', 'type': 'DERIVED', 'citation': 'My I, Moser F, Loeck FW, Obergassel J, Rottner L, Lemoine MD, Kirchhof P, Steven D, Sultan A, Willems S, Meyer C, Reissmann B, Rillig A, Metzner A, Ouyang F. Long-term outcome of catheter ablation of left fascicular ventricular arrhythmias. J Interv Card Electrophysiol. 2025 Aug 14. doi: 10.1007/s10840-025-02116-6. Online ahead of print.'}, {'pmid': '37638409', 'type': 'DERIVED', 'citation': 'Wenzel JP, Lemoine MD, Rottner L, My I, Moser F, Obergassel J, Nies M, Riess J, Ismaili D, Nikorowitsch J, Ouyang F, Kirchhof P, Rillig A, Metzner A, Reissmann B. Nonthermal Point-by-Point Pulmonary Vein Isolation Using a Novel Pulsed Field Ablation System. Circ Arrhythm Electrophysiol. 2023 Sep;16(9):e012093. doi: 10.1161/CIRCEP.123.012093. Epub 2023 Aug 28. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.uke.de/kliniken-institute/kliniken/kardiologie/ueber-die-klinik/bereich-rhythmologie/index.html', 'label': 'Related Info'}, {'url': 'https://www.uke.de/landingpage/uccs/working-groups/working-group-fabritz/index.html', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The "Long-term Outcome and Predictors for Recurrence after Medical and Interventional Treatment of Arrhythmias at the University Heart Center Hamburg" (TRUST) study is an investor-initiated, single-center, prospective clinical cohort study including patients treated with cardiac arrhythmias or at high risk for cardiac arrhythmias. The design enables prospective, low-threshold, near complete inclusion of patients with arrhythmias treated at the UHZ. Collection of routine follow-up data, detailed procedural information and systematic biobanking will enable precise and robust phenotyping.', 'detailedDescription': 'Arrhythmias such as atrial fibrillation, ventricular tachycardia, and sudden death remain major causes of morbidity and mortality. Their prevalence increases in our ageing populations. Modern therapy of these conditions, using a combination of drugs, devices, and interventions, can reduce the disease burden associated with cardiac arrhythmias. This prospective cohort study will collect detailed clinical, procedural, and outcome information in a large cohort of patients with arrhythmias seen in a tertiary care center. Clinical phenotyping will be enhanced by biosampling and analysis of circulating biomolecules. Digital capture of clinical information and of follow-up data is planned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients seen in the Department of Cardiology of the University Heart and Vascular Center Hamburg suffering from cardiac arrhythmias, including congenital cardiac arrhythmias, or being at high risk for cardiac arrhythmias.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cardiac arrhythmia, including congenital cardiac arrhythmia diagnosed at baseline or high risk for cardiac arrhythmia\n* Age ≥ 18 years\n* Written informed consent\n* Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation\n\nExclusion Criteria:\n\n* Insufficient knowledge of the German language to understand study documents and interview without translation\n* Physical or psychological incapability to cooperate in the investigation'}, 'identificationModule': {'nctId': 'NCT05521451', 'acronym': 'TRUST', 'briefTitle': 'Clinical Cohort Study - TRUST', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Longterm Outcome and Predictors for Recurrence After Medical and Interventional Treatment of Arrhythmias At the University Heart Center Hamburg', 'orgStudyIdInfo': {'id': 'CCS_TRUST'}}, 'contactsLocationsModule': {'locations': [{'zip': '20251', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Julius Obergassel, MD', 'role': 'CONTACT', 'email': 'trust@uke.de', 'phone': '+49 (40) 7410 - 58320'}], 'facility': 'University Hospital Hamburg-Eppendorf, University Heart and Vascular Center', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Julius Obergassel, MD', 'role': 'CONTACT', 'email': 'trust@uke.de', 'phone': '+49 (40) 7410 - 58320'}], 'overallOfficials': [{'name': 'Paulus Kirchhof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}, {'name': 'Andreas Metzner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}, {'name': 'Andreas Rillig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}