PT Journal
AU Taborsky, M
   Skala, T
   Aiglova, R
   Fedorco, M
   Kautzner, J
   Jandik, T
   Vancura, V
   Linhart, A
   Valek, M
   Novak, M
   Kala, P
   Polasek, R
   Roubicek, T
   Schee, A
   Hindricks, G
   Dagres, N
   Hatala, R
   Jarkovsky, J
TI Cardiac Resynchronization and Defibrillator Therapy (CRT-D) or CRT Alone (CRT-P) in patients with dilated cardiomyopathy and heart failure without late gadolinium enhancement (LGE) cardiac magnetic resonance imaging (CMRI) high-risk markers - CRT-REALITY study - Study design and rationale
SO Biomedical papers
PY 2022
BP 173
EP 179
VL 166
IS 2
DI 10.5507/bp.2021.015
DE non-ischemic cardiomyopathy; heart failure; implantable cardioverter-defibrillator; cardiac resynchronization therapy; magnetic resonance imaging; late gadolinium enhancement; randomized controlled trial
AB Background. Primary preventive implantation of implantable defibrillator (ICD) is according to current guidelines indicated in patients with heart failure NYHA (New York Heart Association) class II/III and LVEF <35%. Thanks to advances in heart failure pharmacotherapy, a decrease in mortality could render a benefit of ICD insufficient to justify its implantation in some patients. Methods. Study design: multicenter, prospective, randomized, controlled trial evaluating the benefit of implantation of Cardiac Resynchronization and Defibrillator Therapy (CRT-D) or CRT Alone (CRT-P) in non-ischemic patients with reduced left ventricle ejection fraction (LVEF) and optimal pharmacotherapy without significant mid-wall myocardial fibrosis detected by cardiac magnetic resonance (CMR). The primary end-point: Re-hospitalization for heart failure, ventricular tachycardia, major adverse cardiac events (MACE). The secondary end-points: Sudden cardiac death, cardiovascular death, resuscitated cardiac arrest or sustained ventricular tachycardia, device-related complications, and change in quality of life. Course of the study: After a pharmacotherapy is optimized and significant mid-wall myocardial fibrosis excluded, patients will be randomized 1:1 to CRT-P or CRT-D implantation. Discussion. If our hypothesis is confirmed, this could provide evidence for the management of these patients with a significant impact on common daily praxis and health care expenditures. Trial registration. ClinicalTrials.gov, NCT04139460
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