Clinical trial NCT05521451: Clinical Cohort Study - TRUST
Official title: Longterm Outcome and Predictors for Recurrence After Medical and Interventional Treatment of Arrhythmias At the University Heart Center Hamburg
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Keywords: Catheter Ablation
Biomarkers
Cardiac Arrhythmia
eHealth
Digital Cardiology
Echocardiography
Atrial Cardiomyopathy
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to a composite of cardiovascular mortality, stroke, acute coronary syndrome and heart failure hospitalization
timeFrame: Follow-up 5 years after inclusion
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
Secondary outcomes:
measure: Time to recurrence of the clinical arrhythmia
timeFrame: Follow-up 5 years after inclusion
measure: New onset of heart failure
timeFrame: Follow-up 5 years after inclusion
measure: All-cause mortality (Safety Outcome)
timeFrame: Follow-up 5 years after inclusion
measure: Patient reported quality of life (QOL)
timeFrame: Follow-up 5 years after inclusion
measure: Health care utilisation
timeFrame: Follow-up 5 years after inclusion
measure: Complications of rhythm control therapy (Safety Outcome)
timeFrame: Follow-up 5 years after inclusion
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf, University Heart and Vascular Center
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
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
References: