Longterm Outcome and Predictors for Recurrence After Medical and Interventional Treatment of Arrhythmias At the University Heart Center Hamburg
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Enrollment
- 5000
- Locations
- 1
- Primary Endpoint
- New onset of cardiac arrhythmias, documented in clinical care and during systematic rhythm monitoring using digital devices.
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
New onset of cardiac arrhythmias, documented in clinical care and during systematic rhythm monitoring using digital devices.
Time Frame: Follow-up 5 years after inclusion
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 a composite of cardiovascular mortality, stroke, acute coronary syndrome and heart failure hospitalization
Time Frame: Follow-up 5 years after inclusion
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.
Secondary Outcomes
- New onset of heart failure(Follow-up 5 years after inclusion)
- Patient reported quality of life (QOL)(Follow-up 5 years after inclusion)
- Complications of rhythm control therapy (Safety Outcome)(Follow-up 5 years after inclusion)
- All-cause mortality (Safety Outcome)(Follow-up 5 years after inclusion)
- Time to recurrence of the clinical arrhythmia(Follow-up 5 years after inclusion)
- Health care utilisation(Follow-up 5 years after inclusion)