Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network
Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the efficacy and safety of administering an angiotensin converting
enzyme inhibitor (ACE-I) (enalapril) to infants with a functional single ventricle. The study
will also compare the effect of ACE-I therapy to placebo on somatic growth and compare the
effect of ACE-I therapy to placebo on signs and symptoms of heart failure, neurodevelopmental
and functional status, ventricular geometry, function, and atrioventricular (AV) valve
regurgitation. In addition, the study will determine the relationship between genetic
polymorphisms linked to ventricular hypertrophy (enlarged heart) and the response to ACE-I
therapy and compare the incidence of adverse events in subjects treated with ACE-I with those
in subjects treated with placebo.