Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022, 166(2):173-179 | DOI: 10.5507/bp.2021.015

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

Milos Taborsky^a, Tomas Skala^a, Renata Aiglova^a, Marian Fedorco^a, Josef Kautzner^b, Tomas Jandik^c, Vlastimil Vancura^c, Ales Linhart^d, Martin Valek^d, Miloslav Novak^e, Petr Kala^f, Rostislav Polasek^g, Tomas Roubicek^g, Alexandr Schee^h, Gerhard Hindricksⁱ, Nikolaos Dagresⁱ, Robert Hatala^j, Jiri Jarkovsky^k

^a Department of Internal Medicine I - Cardiology, University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic

^b Cardiology Department, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

^c Department of Cardiology, University Hospital Pilzen, Czech Republic

^d The Internal Clinic of Cardiology and Angiology of the First Faculty of Medicine and General Teaching Hospital, Czech Republic

^e St. Anne's University Hospital Brno, Czech Republic

^f University Hospital Brno, Czech Republic

^g Liberec Hospital, Czech Republic

^h Private Cardiovascular Center Karlovy Vary Kardio KV L.T.D., Czech Republic

ⁱ Herzzentrum Leipzig, Germany

^j Cardiological Clinic of National Institute of CV Diseases in Bratislava, Slovak Republic

^k Institute for Biostatistics and Analyses of Faculty of Medicine Brno, Czech Republic

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

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

Received: December 15, 2020; Revised: December 15, 2020; Accepted: February 5, 2021; Prepublished online: March 12, 2021; Published: May 13, 2022  Show citation