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Randomized Controlled Trial
. 2022 May;166(2):173-179.
doi: 10.5507/bp.2021.015. Epub 2021 Mar 12.

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  1 , Tomas Skala  1 , Renata Aiglova  1 , Marian Fedorco  1 , Josef Kautzner  2 , Tomas Jandik  3 , Vlastimil Vancura  3 , Ales Linhart  4 , Martin Valek  4 , Miloslav Novak  5 , Petr Kala  6 , Rostislav Polasek  7 , Tomas Roubicek  7 , Alexandr Schee  8 , Gerhard Hindricks  9 , Nikolaos Dagres  9 , Robert Hatala  10 , Jiri Jarkovsky  11
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Free article
Randomized Controlled Trial

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 et al. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022 May.
Free article

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 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.

Clinicaltrials: gov, NCT04139460.

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

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Conflict of interest statement

The authors report no conflicts of interest in this work.

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