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NCT Number: NCT05521451

Clinical Cohort Study - TRUST

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.

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Key information

Conditions

Arrhythmias, Cardiac Arrhythmogenic Right Ventricular Dysplasia Atrial Cardiomyopathy Atrial Fibrillation Atrial Flutter Atrial Tachycardia Brugada Syndrome Cardiac Conduction System Disease Cardiomyopathies Cardiovascular Abnormalities Cardiovascular Diseases Catecholaminergic Polymorphic Ventricular Tachycardia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Long QT Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Polymorphic Catecholaminergic Ventricular Tachycardia Supraventricular Tachycardia Tachycardia Tachycardia, Supraventricular Tachycardia, Ventricular Torsades de Pointes Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Hamburg-Eppendorf, University Heart and Vascular Center

Hamburg, 20251, Germany

Location status: Recruiting

Location contact

Julius Obergassel, MD

CONTACT

[email protected]

+49 (40) 7410 - 58320

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Time to recurrence of the clinical arrhythmia

    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.

  2. New onset of heart failure

    Time frame: Follow-up 5 years after inclusion

    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.

  3. All-cause mortality (Safety Outcome)

    Time frame: Follow-up 5 years after inclusion

    This endpoint is assessed during the telephone call during remote follow-up and - if not applicable - via consultation of the death registry.

  4. Patient reported quality of life (QOL)

    Time frame: Follow-up 5 years after inclusion

    As assessed via AF Effect on QualiTy of life survey at the timepoint of follow-up.

  5. Health care utilisation

    Time frame: Follow-up 5 years after inclusion

    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.

  6. Complications of rhythm control therapy (Safety Outcome)

    Time frame: Follow-up 5 years after inclusion

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julius Obergassel, MD

CONTACT

[email protected]

+49 (40) 7410 - 58320

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Longterm Outcome and Predictors for Recurrence After Medical and Interventional Treatment of Arrhythmias At the University Heart Center Hamburg

Acronym: TRUST

Important dates

Study start
2021
Primary completion
2026
Study completion
2031
First posted
Aug 30, 2022
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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