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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00669806%3A_____%2F22%3A10435465" target="_blank" >RIV/00669806:_____/22:10435465 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/27283933:_____/21:00009786 RIV/00216224:14110/22:00125206 RIV/00216208:11110/22:10435465 RIV/00216208:11140/22:10435465 a 5 dalších

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=tf59z2yO1u" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=tf59z2yO1u</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.5507/bp.2021.015" target="_blank" >10.5507/bp.2021.015</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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 &lt;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

Název v anglickém jazyce

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

Popis výsledku anglicky

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 &lt;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

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2022

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Biomedical Papers

ISSN

1213-8118

e-ISSN

1804-7521

Svazek periodika

166

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

CZ - Česká republika

Počet stran výsledku

7

Strana od-do

173-179

Kód UT WoS článku

000731340300001

EID výsledku v databázi Scopus

2-s2.0-85130643142