Clinical Cohort Study - TRUST

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Longterm Outcome and Predictors for Recurrence After Medical and Interventional Treatment of Arrhythmias at the University Heart Center Hamburg

Conditions
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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

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cardiac arrhythmia, including congenital cardiac arrhythmia diagnosed at baseline or high risk for cardiac arrhythmia Age ≥ 18 years Written informed consent Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation Exclusion Criteria: Insufficient knowledge of the German language to understand study documents and interview without translation Physical or psychological incapability to cooperate in the investigation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of cardiovascular mortality, stroke, acute coronary syndrome and heart failure hospitalization | 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. | Follow-up 5 years after inclusion | 
| New onset of cardiac arrhythmias, documented in clinical care and during systematic rhythm monitoring using digital devices. | 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. | Follow-up 5 years after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of the clinical arrhythmia | 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. | Follow-up 5 years after inclusion | 
| New onset of heart failure | 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. | Follow-up 5 years after inclusion | 
| All-cause mortality (Safety Outcome) | This endpoint is assessed during the telephone call during remote follow-up and - if not applicable - via consultation of the death registry. | Follow-up 5 years after inclusion | 
| Patient reported quality of life (QOL) | As assessed via AF Effect on QualiTy of life survey at the timepoint of follow-up. | Follow-up 5 years after inclusion | 
| Health care utilisation | 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. | Follow-up 5 years after inclusion | 
| Complications of rhythm control therapy (Safety Outcome) | 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. | Follow-up 5 years after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter Ablation, Biomarkers, Cardiac Arrhythmia, eHealth, Digital Cardiology, Echocardiography, Atrial Cardiomyopathy