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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05521451
Other study ID # CCS_TRUST
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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