Status:
RECRUITING
Early Treatment With Candesartan vs Placebo in Genetic Carriers of Dilated Cardiomyopathy (EARLY-GENE Trial)
Lead Sponsor:
Cristina Avendaño Solá
Conditions:
Cardiomyopathy, Dilated
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
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...
Detailed Description
Prospective, multicenter, randomized, placebo-controlled, double-blind clinical trial to evaluate safety and efficacy of early administration of candesartan in the prevention of the development of Dil...
Eligibility Criteria
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
- 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.
- Uncontrolled arterial hypertension (i.e., repeatedly systolic arterial pressure \> 140 mmHg).
- Carriers of TTN-truncating variants (TTNtv) who are \< 35 years old.
- 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.
- Ongoing treatment with ACEI, ARB, ARNI or MRA.
- Prior intolerance to ACE inhibitors or ARB.
- Presence of any contraindications to receive candesartan treatment, including severe liver failure and/or cholestasis
- Known bilateral renal artery stenosis.
- 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.
- 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)\*.
- Drug or alcohol abuse (current).
- Inability to comply with study procedures and treatments.
- 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.
- Any circumstances that in the investigator's opinion compromise the participant's ability to participate in the clinical trial.
Key Trial Info
Start Date :
June 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 2 2026
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT05321875
Start Date
June 2 2022
End Date
June 2 2026
Last Update
November 7 2024
Active Locations (1)
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1
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, Spain, 28222