NCT05321875

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)"

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Cristina Avendaño Solá · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cardiomyopathy, Dilated

Interventions

Type	Name	Description
DRUG	Candesartan	3 years treatment with candesartan target dose: 32 mg or maximum tolerated dose after dose escalation from 16 mg

Timeline

• Start date: 2022-06-02
• Primary completion: 2026-06-02
• Completion: 2026-06-02
• First posted: 2022-04-11
• Last updated: 2024-11-07

Locations

1 site across 1 country: Spain