PT  - JOURNAL ARTICLE
AU  - Taborsky, Milos
AU  - Skala, Tomas
AU  - Aiglova, Renata
AU  - Fedorco, Marian
AU  - Kautzner, Josef
AU  - Jandik, Tomas
AU  - Vancura, Vlastimil
AU  - Linhart, Ales
AU  - Valek, Martin
AU  - Novak, Miloslav
AU  - Kala, Petr
AU  - Polasek, Rostislav
AU  - Roubicek, Tomas
AU  - Schee, Alexandr
AU  - Hindricks, Gerhard
AU  - Dagres, Nikolaos
AU  - Hatala, Robert
AU  - Jarkovsky, Jiri
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
DP  - 2022 May 13
TA  - Biomedical papers
PG  - 173--179
VI  - 166
IP  - 2
AID - 10.5507/bp.2021.015
IS  - 12138118
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