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

NCT05321875 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2024-11-07

No results posted yet for this study

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)

Conditions

  • Cardiomyopathy, Dilated

Interventions

DRUG

Candesartan

3 years treatment with candesartan target dose: 32 mg or maximum tolerated dose after dose escalation from 16 mg

Sponsors & Collaborators

  • Cristina Avendaño Solá

    lead OTHER

Principal Investigators

  • Pablo García-Pavía, MD, PhD · Hospital Universitario Puerta de Hierro Majadahonda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-02
Primary Completion
2026-06-02
Completion
2026-06-02

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05321875 on ClinicalTrials.gov