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, 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 Hatala, Jiri Jarkovsky, Milos Taborsky, 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 Hatala, Jiri Jarkovsky

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.

Conflict of interest statement

The authors report no conflicts of interest in this work.

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