TABORSKY, Milos, Tomas SKALA, Renata AIGLOVA, Marian FEDORCO, Josef KAUTZNER, Tomas JANDIK, Vlastimil VANCURA, Ales LINHART, Martin VALEK, Miloslav NOVAK, Petr KALA, Rostislav POLASEK, Tomas ROUBICEK, Alexandr SCHEE, Gerhard HINDRICKS, Nikolaos DAGRES, Robert HATALAJ and Jiří JARKOVSKÝ. 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. Biomedical Papers, Olomouc: Palacky University. Olomouc: Palacky University, 2022, vol. 166, No 2, p. 173-179. ISSN 1213-8118. Available from: https://dx.doi.org/10.5507/bp.2021.015.
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Basic information
Original name 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
Authors TABORSKY, Milos (203 Czech Republic), Tomas SKALA (203 Czech Republic), Renata AIGLOVA (203 Czech Republic), Marian FEDORCO (203 Czech Republic), Josef KAUTZNER (203 Czech Republic), Tomas JANDIK (203 Czech Republic), Vlastimil VANCURA (203 Czech Republic), Ales LINHART, Martin VALEK (203 Czech Republic), Miloslav NOVAK (203 Czech Republic), Petr KALA, Rostislav POLASEK (203 Czech Republic), Tomas ROUBICEK (203 Czech Republic), Alexandr SCHEE, Gerhard HINDRICKS, Nikolaos DAGRES, Robert HATALAJ and Jiří JARKOVSKÝ (203 Czech Republic, belonging to the institution).
Edition Biomedical Papers, Olomouc: Palacky University, Olomouc, Palacky University, 2022, 1213-8118.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30201 Cardiac and Cardiovascular systems
Country of publisher Czech Republic
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 0.900
RIV identification code RIV/00216224:14110/22:00125206
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.5507/bp.2021.015
UT WoS 000731340300001
Keywords in English non-ischemic cardiomyopathy; heart failure; implantable cardioverter-defibrillator; cardiac resynchronization therapy; magnetic resonance imaging; late gadolinium enhancement; randomized controlled trial
Tags 14119612, rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 20/7/2022 09:03.
Abstract
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 ad-vances 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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