Heart Failure, Congestive Clinical Trial
Official title:
Trial of ACE Inhibition in Children With Mitral Regurgitation After Repair of AVSD
This study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition (ACE-I) therapy for the treatment of mitral regurgitation (MR).
BACKGROUND:
MR causes volume overload and hemodynamic burden on the left ventricle. Initial compensatory
mechanisms may fail, leading to increased severity. Patients who have had repair of an
atrioventricular septal defect (AVSD) are selected for this study as they have a relatively
high incidence of moderate MR and their regurgitant orifice is mobile and dynamic,
contributing to the likelihood that they might respond to medical therapy.
DESIGN NARRATIVE:
This is a randomized, double-blind, placebo-controlled trial of ACE-I therapy in children
less than 18 years of age with at least moderate MR who are at least 6 months postoperative
from repair of an AVSD. A non-randomized Observational Phase enrolled 181 children who were
less than 6 months postoperative from repair of an AVSD, who were then evaluated at 6 months
for trial eligibility.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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