CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy international registry: Design and rationale of the DERIVATE study

Abstract

BackgroundImplantable cardioverter defibrillator (ICD) represents the most valuable sudden cardiac death (SCD) prophylactic strategy in patients with heart failure and severely reduced left ventricular ejection fraction (LVEF). To date, it is still unknown how to integrate the information given by cardiac magnetic resonance (CMR) into clinical and transthoracic echocardiography (TTE) work-up of non-ischemic cardiomyopathy (NICM) and ischemic cardiomyopathy (ICM) patients for accurate risk stratification. Methods and resultsDERIVATE is a prospective, international, multicenter, observational registry of NICM and ICM patients with chronic heart failure and reduced LVEF who will undergo clinical evaluation, TTE and CMR. The registry will enrol cohorts from 34 sites. Complete risk factor, clinical presentation, TTE and CMR data will be collected and each patient will be followed-up for outcomes. Primary end point of the study is all-cause mortality. Secondary end points are: cardiovascular death, SCD, aborted SCD, sustained ventricular tachycardia (VT), and major adverse cardiac events (MACE) defined as a composite endpoint of SCD, aborted SCD, and sustained VT. Specifically, we will determine CMR findings that predict outcomes, with incremental value over LVEF and NYHA classification. Secondary aims consist in providing a comprehensive clinical and imaging score and testing the contribution of machine learning to determine prognostic CMR parameters. ConclusionsThe final objective of the study consists in the identification of prognostic CMR parameters in a large prospective cohort for a better selection of patients with heart failure being worthy of primary prevention ICD therapy. (clinicaltrials.gov registration: RTT# NCT03352648).