Clinical Cohort Study - TRUST

Universitätsklinikum Hamburg-Eppendorf5,000 enrolled

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.

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 Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Ventricular Tachycardia

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time to a 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.