Clinical Cohort Study - TRUST

Recruiting

• Conditions: Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter; Ventricular Tachycardia; Arrhythmogenic Right Ventricular Dysplasia; Long QT Syndrome; Atrial Tachycardia; Brugada Syndrome; Supraventricular Tachycardia; Catecholaminergic Polymorphic Ventricular Tachycardia

• Registration Number: NCT05521451
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-03-17
• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-09-30
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
New onset of cardiac arrhythmias, documented in clinical care and during systematic rhythm monitoring using digital devices.	Follow-up 5 years after inclusion	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.
Time to a composite of cardiovascular mortality, stroke, acute coronary syndrome and heart failure hospitalization	Follow-up 5 years after inclusion	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Hamburg-Eppendorf, University Heart and Vascular Center; 🇩🇪 Hamburg, Germany