Title: Rationale, objectives, and design of the EUTrigTreat clinical study: a prospective observational study for arrhythmia risk stratification and assessment of interrelationships among repolarization markers and genotype
Authors: Seegers, Joachim ×
Vos, Marc A
Flevari, Panagiota
Willems, Rik
Sohns, Christian
Vollmann, Dirk
Lüthje, Lars
Kremastinos, Dimitrios T
Floré, Vincent
Meine, Mathias
Tuinenburg, Anton
Myles, Rachel C
Simon, Dirk
Brockmöller, Jürgen
Friede, Tim
Hasenfuß, Gerd
Lehnart, Stephan E
Zabel, Markus
for the EUTrigTreat Clinical Study Investigators #
Issue Date: Mar-2012
Publisher: W.B. Saunders
Series Title: Europace vol:14 issue:3 pages:416-22
Abstract: AimsThe EUTrigTreat clinical study has been designed as a prospective multicentre observational study and aims to (i) risk stratify patients with an implantable cardioverter defibrillator (ICD) for mortality and shock risk using multiple novel and established risk markers, (ii) explore a link between repolarization biomarkers and genetics of ion (Ca(2+), Na(+), K(+)) metabolism, (iii) compare the results of invasive and non-invasive electrophysiological (EP) testing, (iv) assess changes of non-invasive risk stratification tests over time, and (v) associate arrythmogenomic risk through 19 candidate genes.Methods and resultsPatients with clinical ICD indication are eligible for the trial. Upon inclusion, patients will undergo non-invasive risk stratification, including beat-to-beat variability of repolarization (BVR), T-wave alternans, T-wave morphology variables, ambient arrhythmias from Holter, heart rate variability, and heart rate turbulence. Non-invasive or invasive programmed electrical stimulation will assess inducibility of ventricular arrhythmias, with the latter including recordings of monophasic action potentials and assessment of restitution properties. Established candidate genes are screened for variants. The primary endpoint is all-cause mortality, while one of the secondary endpoints is ICD shock risk. A mean follow-up of 3.3 years is anticipated. Non-invasive testing will be repeated annually during follow-up. It has been calculated that 700 patients are required to identify risk predictors of the primary endpoint, with a possible increase to 1000 patients based on interim risk analysis.ConclusionThe EUTrigTreat clinical study aims to overcome current shortcomings in sudden cardiac death risk stratification and to answer several related research questions. The initial patient recruitment is expected to be completed in July 2012, and follow-up is expected to end in September identifier: NCT01209494.
ISSN: 1099-5129
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Cardiology
Experimental Cardiology
× corresponding author
# (joint) last author

Files in This Item:

There are no files associated with this item.

Request a copy


All items in Lirias are protected by copyright, with all rights reserved.

© Web of science