Actively Recruiting
Early Treatment With Candesartan vs Placebo in Genetic Carriers of Dilated Cardiomyopathy (EARLY-GENE Trial)
Led by Cristina Avendaño Solá · Updated on 2024-11-07
320
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Early Treatment With Candesartan vs Placebo in Genetic Carriers of Dilated Cardiomyopathy (EARLY-GENE Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 64 years, any gender
- Carrier of a pathogenic or likely pathogenic genetic variant causing dilated cardiomyopathy
- Baseline left ventricular ejection fraction (LVEF) of 50% or higher measured by MRI
- Baseline creatinine level of 1.3 mg/dL or less, potassium level of 5.3 mEq/L or less, and estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73 m2 or higher
- Able to understand study procedures and give informed consent
You will not qualify if you...
- Systolic blood pressure below 100 mmHg
- History of ventricular dysfunction with LVEF 50% or less
- Expected to need an implantable cardioverter defibrillator (ICD) within 12 months
- Hypertension requiring medication or uncontrolled hypertension with systolic blood pressure above 140 mmHg
- Carriers of TTN-truncating variants younger than 35 years
- Known significant coronary artery disease, moderate or worse valvular disease, or ventricular arrhythmias
- Current treatment with ACE inhibitors, ARBs, ARNI, or MRA
- Previous intolerance to ACE inhibitors or ARBs
- Contraindications to candesartan including severe liver failure or cholestasis
- Known bilateral renal artery stenosis
- Severe uncontrolled diseases with expected survival shorter than study duration
- Participation in another clinical trial with an investigational product or device within 30 days
- Current pregnancy, breastfeeding, or unwillingness to use birth control during the study
- Current drug or alcohol abuse
- Unable to comply with study procedures or treatments
- Presence of MRI-incompatible internal devices or contraindications to MRI
- Any condition that might compromise ability to participate as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
Research Team
C
Cristina Avendaño-Solá, MD, PhD
CONTACT
A
Ana Velasco-Iglesias, Msc,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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