Loading clinical trials...

RECRUITINGPHASE3

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

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

NCT05321875•Cristina Avendaño Solá

View on ClinicalTrials.gov

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)

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 Dilated Cardiomyopathy (DCM) in genetic carriers of a DCM-causing variant without disease expression (asymptomatic). Randomization will be 1:1 and patients are allocated to candesartan or matching placebo. Patients will be followed for a 3 years period and efficacy will be demonstrated if candesartan (compared to placebo) prevents either a significant Left ventricular ejection fraction (LVEF) decline of ≥10%, or a ventricular dilatation (left ventricular end-diastolic volume, LVEDV) increase of ≥10% within a 3-years period of follow-up

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

Locations (1)

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, Madrid, Spain

Key Dates

Start Date

June 2, 2022

Primary Completion Date

June 2, 2026

Completion Date

June 2, 2026

Last Updated

November 7, 2024

Enrollment

320

ESTIMATED participants

Conditions

Cardiomyopathy, Dilated

Interventions

Candesartan

DRUG

Contacts

Cristina Avendaño-Solá, MD, PhD

CONTACT

+34 91 1916479 cavendano@salud.madrid.org

Ana Velasco-Iglesias, Msc,PhD

CONTACT

+34 91 1917867 avelasco.idiphim@gmail.com

Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction

NCT03533517

Heart FailureCardiomyopathy, Dilated

View study

COMPLETED

French National Observatory Tracking Viral Myocarditis: Mortality, Cardiovascular Events, Sequels on (Magnetic Resonance Imaging) MRI

NCT02717143

MyocarditisCardiomyopathy, Dilated+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction

French National Observatory Tracking Viral Myocarditis: Mortality, Cardiovascular Events, Sequels on (Magnetic Resonance Imaging) MRI

Ventricular Sling for Heart Failure With Reduced Ejection Fraction

Individualized Early Risk Assessment for Heart Diseases

Mental Stress Reduction in Defibrillator Patients

Characterization of Irreversible Myocardial Injury in Cardiomyopathies by Contrast-enhanced CMR