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

Robert Hatala¹  Josef Kautzner²  Tomas Jandik³  Vlastimil Vancura³  Tomas Skala⁴  Marian Fedorco⁴  Renata Aiglova⁴  Milos Taborsky⁴  Nikolaos Dagres⁵  Gerhard Hindricks⁵  Jiri Jarkovsky⁶  Rostislav Polasek⁷  Tomas Roubicek⁷  Alexandr Schee⁸  Miloslav Novak⁹  Martin Valek^1,10  Ales Linhart^1,10  Petr Kala^1,11 

[1] Cardiological Clinic of National Institute of CV Diseases in Bratislava, Slovak Republic;Cardiology Department, Institute for Clinical and Experimental Medicine, Prague, Czech Republic;Department of Cardiology, University Hospital Pilzen, Czech Republic;Department of Internal Medicine I - Cardiology, University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic;Herzzentrum Leipzig, Germany;Institute for Biostatistics and Analyses of Faculty of Medicine Brno, Czech Republic;Liberec Hospital, Czech Republic;Private Cardiovascular Center Karlovy Vary Kardio KV L.T.D., Czech Republic;St. Anne's University Hospital Brno, Czech Republic;The Internal Clinic of Cardiology and Angiology of the First Faculty of Medicine and General Teaching Hospital, Czech Republic;University Hospital Brno, Czech Republic;

关键词: non-ischemic cardiomyopathy;    heart failure;    implantable cardioverter-defibrillator;    cardiac resynchronization therapy;    magnetic resonance imaging;    late gadolinium enhancement;    randomized controlled trial;   

DOI  :  10.5507/bp.2021.015

来源: DOAJ

【 摘 要 】

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

【 授权许可】

Unknown