PREclinical Mutation CARriers From Families With DIlated Cardiomyopathy and ACE Inhibitors
Status:
Terminated
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
This is a multicentre European double-blind,randomized and controlled trial with 2 parallel
groups (1 study medication, 1 placebo) in order to analyse the impact of ACE inhibitors
(ACEi) in subjects who carry a mutation but have not yet developed DCM (dilated
cardiomyopathy).
Objective of the trial: Study the impact of ACE inhibitors (ACEi) in subjects who carry a
mutation (leading to a genetic form of heart failure) but have not yet developed DCM.
Context. Dilated Cardiomyopathy (DCM) is one of the leading causes of Heart Failure due to
systolic dysfunction and at least 30% of DCM are of familial/genetic origin, usually with
autosomal dominant inheritance, and underlying genes and mutations are increasingly
identified. Familial Dilated Cardiomyopathy (fDCM) is characterized by age-related penetrance
(or delayed-onset), that means that the cardiac expression of the disease (echocardiographic
abnormalities) is usually absent for a long period and progressively appears with advanced
age, usually after 20 years of age
Hypothesis : ACEi may delay or prevent the occurrence of DCM in these subjects (pre-clinical
stage).
Expected results: If the hypothesis is confirmed, and as a consequence, the knowledge derived
from basic research (genes identification in DCM) will be translated into clinical practice
(early identification of subjects at high risk of developing heart failure through predictive
genetic testing) with the development of new therapeutic management (early ACEi) that will
help to decrease the morbidity and mortality associated with the disease. This will
constitute a paradigm of the development of preventive medicine thanks to the development of
genetics in the cardiovascular field.
Subjects who are concerned are ≥18 years of age and ≤60 years, carry a mutation responsible
for DCM and are at a preclinical stage of the disease. Total duration of treatment
(perindopril versus placebo) is 3 years. A total number of 200 participants will be enrolled
(100 in each group) in 7 centres.
Phase:
Phase 3
Details
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France