RT Journal Article
SR Electronic
A1 Taborsky, Milos
A1 Skala, Tomas
A1 Aiglova, Renata
A1 Fedorco, Marian
A1 Kautzner, Josef
A1 Jandik, Tomas
A1 Vancura, Vlastimil
A1 Linhart, Ales
A1 Valek, Martin
A1 Novak, Miloslav
A1 Kala, Petr
A1 Polasek, Rostislav
A1 Roubicek, Tomas
A1 Schee, Alexandr
A1 Hindricks, Gerhard
A1 Dagres, Nikolaos
A1 Hatala, Robert
A1 Jarkovsky, Jiri
T1 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
JF Biomedical papers
YR 2022
VO 166
IS 2
SP 173
OP 179
DO 10.5507/bp.2021.015
UL https://biomed.papers.upol.cz/artkey/bio-202202-0008.php
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