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

Recruiting Phase 3 Interventional Study
Cardiomyopathy, Dilated
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 64
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
320 (estimated)
Sponsor
Cristina Avendaño Solá · Other
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About This 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)

Trial Locations
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Eligibility Criteria
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. Carri…
Contacts

Cristina Avendaño-Solá, MD, PhD

+34 91 1916479

cavendano@salud.madrid.org

CONTACT

Ana Velasco-Iglesias, Msc,PhD

+34 91 1917867

avelasco.idiphim@gmail.com

CONTACT