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Clinical Cohort Study - TRUST

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

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 details

Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia

NCT05521451

Universitätsklinikum Hamburg-Eppendorf

25 January 2024

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