An Arrhythmia Risk Stratification and Genetic Trial

Summary

The prospective EUTrigTreat multi-center study is an observational, advanced diagnostics and genetic risk stratification trial in patients with standard indications for ICD treatment, with and without myocardial infarction in their history.

Its aims are fourfold: 1) To accurately risk stratify a large cohort of implantable cardioverter-defibrillator (ICD) patients for ICD shock risk and mortality using traditional risk markers as well as genetic markers 2) To find a link between repolarization biomarkers and genetic markers of calcium metabolism. 3) To compare invasive and noninvasive electrophysiologic (EP) testing systematically 4) To assess temporal changes of typical noninvasive risk stratifiers and their prognostic implication.

In five European academic clinical centers, 700 ICD patients are prospectively enrolled (optionally the number of enrolled patients may be expanded to 1000 patients). Comprehensive non-invasive risk stratifying ECG diagnostics including beat-to-beat variability of repolarization (BVR) are applied, and candidate genes associated with malignant arrhythmias are analyzed. Programmed electrical stimulation is performed to test for inducibility of malignant ventricular arrhythmias and BVR. In a subset of patients, electrophysiologic studies include recording of monophasic action potentials (MAP) from the right ventricle for assessment of restitution properties. Non-invasive risk stratifying ECG methods are repeated annually. Outcome (mortality, ICD shocks) will be assessed until September 2014.

Conditions

• Cardiomyopathies, Primary
• Arrhythmia
• Sudden Cardiac Death
• Calcium Metabolism Disorders

Sponsors & Collaborators

• UMC Utrecht

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• University of Athens

  collaborator OTHER

• University Medical Center Goettingen

  lead OTHER

Principal Investigators

• Markus Zabel, M.D. · University Medical Center Goettingen

• Marc A. Vos, Ph.D. · UMC Utrecht

• Panagotia Flevari, M.D. · University of Athens

• Rik Willems, M.D. · KU Leuven

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2014-02-28

Completion

2014-09-30

Countries

• Belgium
• Germany
• Greece
• Netherlands

Study Locations