This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OVERVIEW (ABSTRACT) Angiotensin converting enzyme (ACE) inhibitors are widely used in the treatment of infants with severe congestive heart failure to improve cardiac function and somatic growth. This multi-center, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of administering the ACE inhibitor enalapril to infants with a functional single ventricle. Infants up to age 45 days with single ventricle physiology who have undergone neonatal surgery to establish stable systemic and pulmonary blood flows will be eligible for inclusion in this study. After stratification by ventricular anatomy, neonates will be randomly assigned to receive enalapril or placebo and then followed for 14 1 months. Data will be collected at two time points: before palliative surgery at approximately age 6 months and at age 14 1 months (a minimum of 6 months post-palliative surgery for most infants). The primary aim of the study is to compare the effect of ACE inhibition to placebo on weight-for-age Z-score at age 14 1 months. Secondary aims include comparison of other measures of somatic growth (height- and head circumference-for-age Z-scores), signs and symptoms of congestive heart failure, developmental indices, and echocardiographic and magnetic resonance imaging (MRI) measures of ventricular mass, volume and function in the subjects in the two groups. The incidence of adverse events will also be compared between the treatment groups. The total sample size target of 216 patients is to be recruited over 18 months.
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