Candesartan treatment for genetic carriers of dilated cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of candesartan in preventing dilated cardiomyopathy (DCM) in asymptomatic genetic carriers of DCM-causing variants. It is a multicenter, randomized, placebo-controlled, double-blind study where participants are assigned to receive either candesartan or a matching placebo. Over a three-year follow-up period, the trial aims to determine if candesartan can prevent significant declines in left ventricular ejection fraction or increases in left ventricular end-diastolic volume. The study involves rigorous eligibility criteria to ensure the safety and appropriateness of participants.

Why it matters

Who can join: the full rules

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 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.

Where it's running

• Hospital Universitario Puerta de Hierro-Majadahonda
  Majadahonda, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Cristina Avendaño-Solá, MD, PhD
• Email: cavendano@salud.madrid.org
• Phone: +34 91 1916479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry of cell therapy for non-ischemic dilated cardiomyopathy

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• Natural history of BAG3-related dilated cardiomyopathy in Chinese adults

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.