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.
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
Insufficient knowledge of the German language to understand study documents and interview without translation
Physical or psychological incapability to cooperate in the investigation
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.
Cohort
Prospective
Not listed
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.
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.
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.
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.
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.
Patient reported quality of life (QOL)
As assessed via AF Effect on QualiTy of life survey at the timepoint of follow-up.
Click on the lead sponsor to view all of their trials.
