Early Treatment With Candesartan vs Placebo in Genetic Carriers of Dilated Cardiomyopathy (EARLY-GENE Trial)
Trial Parameters
Brief Summary
Prospective, multicenter, randomized, placebo-controlled, double-blind clinical trial to evaluate safety and efficacy of candesartan in the prevention of the development of Dilated Cardiomyopathy (DCM) in genetic carriers of a DCM-causing variant without disease expression (asymptomatic)
Eligibility Criteria
Inclusion Criteria: * Age: 18-64 (both included), both sexes * Carrier of a pathogenic or likely pathogenic DCM genetic variant1 according to modified American College of Medical Genetics (ACMG) criteria. * Baseline LVEF ≥ 50% measured by MRI1 and evaluated by the eligibility study committee. Carriers with myocardial fibrosis, detected by late gadolinium enhancement in magnetic resonance imaging, are valid. * Baseline creatinine ≤1.3 mg/dL, potassium ≤ 5.3 mEq/L and an estimated Glomerular Filtration Rate (eGFR)≥ 60 ml/min/1.73 m2 calculated by CKD-EPI formula. * Able to understand and accept the study constraints and to provide informed consent. Exclusion Criteria: * Hypotension (systolic arterial pressure \<100 mmHg (measured following a standardized methodology). * Prior ventricular dysfunction (LVEF ≤ 50% at any time prior to study inclusion) * Candidates who are expected or highly likely to receive an implantable cardioverter defibrillator (ICD) in the following 12 months after in