Clinical Cohort Study - TRUST (TRUST)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Ventricular Tachycardia; Atrial Flutter; Supraventricular Tachycardia; Brugada Syndrome; Atrial Tachycardia; Torsades de Pointes; Long QT Syndrome; Arrhythmogenic Right Ventricular Dysplasia; Catecholaminergic Polymorphic Ventricular Tachycardia; Atrial Cardiomyopathy

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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Julius Obergassel, MD; Phone Number: +49 (40) 7410 - 58320; Email: trust@uke.de

Study Locations

• Germany
  • Hamburg, Germany, 20251
    • Recruiting
    • University Hospital Hamburg-Eppendorf, University Heart and Vascular Center
    • Contact: Julius Obergassel, MD; Phone Number: +49 (40) 7410 - 58320; Email: trust@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	Follow-up 5 years after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time to 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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Paulus Kirchhof, MD, Universitätsklinikum Hamburg-Eppendorf; Principal Investigator: Andreas Metzner, MD, Universitätsklinikum Hamburg-Eppendorf; Principal Investigator: Andreas Rillig, MD, Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 1, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Catheter Ablation; Biomarkers; eHealth; Echocardiography; Cardiac Arrhythmia; Digital Cardiology; Atrial Cardiomyopathy
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Syndrome; Atrial Fibrillation; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular; Cardiomyopathies; Atrial Flutter; Tachycardia, Supraventricular; Brugada Syndrome; Torsades de Pointes; Long QT Syndrome; Arrhythmogenic Right Ventricular Dysplasia
• Other Study ID Numbers: CCS_TRUST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No