An observational study in Arrhythmias, Cardiac, Atrial Fibrillation and Atrial Flutter, sponsored by Universitätsklinikum Hamburg-Eppendorf. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational
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.
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.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 200 across 467 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: Follow-up 5 years after inclusion
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 frame: 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.
Time frame: Follow-up 5 years after inclusion
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Follow-up 5 years after inclusion
Plan to share: Undecided
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