Clinical Cohort Study - TRUST

Atrial Fibrillation Clinical Trial

— TRUST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05521451
• Other study ID #: CCS_TRUST
• Status: Recruiting
• Start date: March 17, 2021
• Est. completion date: December 31, 2031

Study information

• Verified date: January 2024
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Julius Obergassel, MD
• Phone: +49 (40) 7410 - 58320
• Email: trust[@]uke.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2031
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrhythmogenic Right Ventricular Dysplasia
• Atrial Fibrillation
• Atrial Flutter
• Atrial Tachycardia
• Brugada Syndrome
• Cardiomyopathies
• Catecholaminergic Polymorphic Ventricular Tachycardia
• Long QT Syndrome
• Supraventricular Tachycardia
• Syndrome
• Tachycardia
• Tachycardia, Supraventricular
• Tachycardia, Ventricular
• Torsades de Pointes
• Ventricular Tachycardia

Locations

Country	Name	City	State
Germany	University Hospital Hamburg-Eppendorf, University Heart and Vascular Center	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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