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)
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.
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 inclusion in the trial
Preexisting hypertension requiring pharmacological treatment.
Parallel
Candesartan
Drug3 years treatment with candesartan target dose: 32 mg or maximum tolerated dose after dose escalation from 16 mg
Proportion of participants that progress to either a LVEF or LVEDV deterioration of ≥10% with respect to the baseline value at the end of follow-up as measured by MRI
Proportion of participants that progress to a LVEF deterioration of ≥10% compared to baseline value at the end of follow-up as measured by MRI.
Proportion of participants that progress to a LVEDV deterioration of ≥10% compared to baseline value at the end of follow-up as measured by MRI.
Changes in LVEF measured by MRI (vs baseline)
Changes in LVEDV measured by MRI (vs baseline)
Proportion of participants developing new cardiac fibrosis and its extent measured by MRI in the candesartan and placebo groups.
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Cristina Avendaño Solá
Lead sponsor
Puerta de Hierro University Hospital
Sponsor institution
