Early Treatment With Candesartan vs Placebo in Genetic Carriers of Dilated Cardiomyopathy (EARLY-GENE Trial)

Trial details

Who runs it

Cristina Avendaño Solá

Trial code

NCT05321875EU 2023-507029-40-00

Record updated

7 November 2024

Original description

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)Read full original descriptionShow less

Early Treatment With Candesartan vs Placebo in Asymptomatic Genetic Carriers of Dilated Cardiomyopathy (EARLY-GENE Trial)"

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)

Inclusion: 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: Ongoing treatment with ACEI, ARB, ARNI or MRA; Prior intolerance to ACE inhibitors or ARB; Uncontrolled concomitant severe disease (e.g., with expected survival inferior to the duration of the study follow-up); Participation in any other clinical trial using an investigational medicinal product or device in the 30 days previous to the inclusion in the study; Drug or alcohol abuse (current); Preexisting hypertension requiring pharmacological treatment; Uncontrolled arterial hypertension (i.e., repeatedly systolic arterial pressure > 140 mmHg); Known clinically significant coronary artery disease (e.g., ≥70% stenosis in any epicardial artery or ≥50% of left main coronary artery), valvular disease (≥ moderate in severity) or ventricular arrhythmias; Presence of any contraindications to receive candesartan treatment, including severe liver failure and/or cholestasis; Carriers of MRI incompatible internal devices (ICD, pacemakers, aneurysm clips, etc.), with known intolerance to MRI studies or presenting any contraindications to perform cardiac MRI studies; Prior ventricular dysfunction (LVEF ≤ 50% at any time prior to study inclusion); Carriers of TTN-truncating variants (TTNtv) who are < 35 years old; Current pregnancy, breastfeeding or women of childbearing age who are not willing to practice an adequate birth control during the entire duration of the study (a negative pregnancy test result must be confirmed at the time of enrolment)*; Hypotension (systolic arterial pressure <100 mmHg (measured following a standardized methodology); Candidates who are expected or highly likely to receive an implantable cardioverter defibrillator (ICD) in the following 12 months after inclusion in the trial; Known bilateral renal artery stenosis; Inability to comply with study procedures and treatments; Any circumstances that in the investigator's opinion compromise the participant's ability to participate in the clinical trial.

ClinicalTrials.gov NCT05321875 · EU CTIS 2023-507029-40-00