Clinical Cohort Study - TRUST
TRUST
Longterm Outcome and Predictors for Recurrence After Medical and Interventional Treatment of Arrhythmias At the University Heart Center Hamburg
1 other identifier
observational
5,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 17, 2021
CompletedFirst Submitted
Initial submission to the registry
August 22, 2022
CompletedFirst Posted
Study publicly available on registry
August 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
March 30, 2025
March 1, 2025
5.5 years
August 22, 2022
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (6)
Time to recurrence of the clinical arrhythmia
Follow-up 5 years after inclusion
New onset of heart failure
Follow-up 5 years after inclusion
All-cause mortality (Safety Outcome)
Follow-up 5 years after inclusion
Patient reported quality of life (QOL)
Follow-up 5 years after inclusion
Health care utilisation
Follow-up 5 years after inclusion
- +1 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Insufficient knowledge of the German language to understand study documents and interview without translation
- Physical or psychological incapability to cooperate in the investigation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Hamburg-Eppendorf, University Heart and Vascular Center
Hamburg, 20251, Germany
Related Publications (2)
My I, Moser F, Loeck FW, Obergassel J, Rottner L, Lemoine MD, Kirchhof P, Steven D, Sultan A, Willems S, Meyer C, Reissmann B, Rillig A, Metzner A, Ouyang F. Long-term outcome of catheter ablation of left fascicular ventricular arrhythmias. J Interv Card Electrophysiol. 2026 Jan;69(1):35-41. doi: 10.1007/s10840-025-02116-6. Epub 2025 Aug 14.
PMID: 40810874DERIVEDWenzel JP, Lemoine MD, Rottner L, My I, Moser F, Obergassel J, Nies M, Riess J, Ismaili D, Nikorowitsch J, Ouyang F, Kirchhof P, Rillig A, Metzner A, Reissmann B. Nonthermal Point-by-Point Pulmonary Vein Isolation Using a Novel Pulsed Field Ablation System. Circ Arrhythm Electrophysiol. 2023 Sep;16(9):e012093. doi: 10.1161/CIRCEP.123.012093. Epub 2023 Aug 28. No abstract available.
PMID: 37638409DERIVED
Related Links
Biospecimen
Blood sampling at baseline: Whole blood, serum, cellular RNA Collection of tissue samples excised in clinical routine (e. g. left atrial appendages after surgical closure)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paulus Kirchhof, MD
Universitätsklinikum Hamburg-Eppendorf
- PRINCIPAL INVESTIGATOR
Andreas Metzner, MD
Universitätsklinikum Hamburg-Eppendorf
- PRINCIPAL INVESTIGATOR
Andreas Rillig, MD
Universitätsklinikum Hamburg-Eppendorf
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2022
First Posted
August 30, 2022
Study Start
March 17, 2021
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 31, 2031
Last Updated
March 30, 2025
Record last verified: 2025-03