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)
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
320
3 years treatment with candesartan target dose: 32 mg or maximum tolerated dose after dose escalation from 16 mg
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, Spain
RECRUITINGProportion of participants that progress to either a LVEF or LVEDV deterioration of ≥10% with respect to the baseline value at the end of follow-up as measured by MRI
Time frame: 3 years
Proportion of participants that progress to a LVEF deterioration of ≥10% compared to baseline value at the end of follow-up as measured by MRI.
Time frame: 3 years
Proportion of participants that progress to a LVEDV deterioration of ≥10% compared to baseline value at the end of follow-up as measured by MRI.
Time frame: 3 years
Changes in LVEF measured by MRI (vs baseline)
Time frame: 3 years
Changes in LVEDV measured by MRI (vs baseline)
Time frame: 3 years
Proportion of individuals who develop DCM (LVEF<50%).
Time frame: 3 years
Proportion of participants in each treatment group developing Serious Adverse Events (SAEs), Grade 3-4 adverse events (AEs), Adverse Reactions, or AEs of Special Interest (AESIs).
Time frame: 3 years
Proportion of treatment discontinuations in the candesartan and placebo groups.
Time frame: 3 years
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