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Enalapril in infants with single ventricle: results of a multicenter randomized trial. Circulation 2010 Jul 27;122(4):333-40

Date

07/14/2010

Pubmed ID

20625111

Pubmed Central ID

PMC3692364

DOI

10.1161/CIRCULATIONAHA.109.927988

Abstract

BACKGROUND: Angiotensin-converting enzyme inhibitor therapy improves clinical outcome and ventricular function in adults with heart failure. Infants with single-ventricle physiology have poor growth and are at risk for abnormalities in ventricular systolic and diastolic function. The ability of angiotensin-converting enzyme inhibitor therapy to preserve ventricular function and improve somatic growth and outcomes in these infants is unknown.

METHODS AND RESULTS: The Pediatric Heart Network conducted a double-blind trial involving 230 infants with single-ventricle physiology randomized to receive enalapril (target dose 0.4 mg . kg(-1) . d(-1)) or placebo who were followed up until 14 months of age. The primary end point was weight-for-age z score at 14 months. The primary analysis was intention to treat. A total of 185 infants completed the study. There were 24 and 21 withdrawals or deaths in the enalapril and placebo groups, respectively (P=0.74). Weight-for-age z score was not different between the enalapril and placebo groups (mean+/-SE -0.62+/-0.13 versus -0.42+/-0.13, P=0.28). There were no significant group differences in height-for-age z score, Ross heart failure class, brain natriuretic peptide concentration, Bayley scores of infant development, or ventricular ejection fraction. The incidence of death or transplantation was 13% and did not differ between groups. Serious adverse events occurred in 88 patients in the enalapril group and 87 in the placebo group.

CONCLUSIONS: Administration of enalapril to infants with single-ventricle physiology in the first year of life did not improve somatic growth, ventricular function, or heart failure severity. The results of this randomized trial do not support the routine use of enalapril in this population.

Author List

Hsu DT, Zak V, Mahony L, Sleeper LA, Atz AM, Levine JC, Barker PC, Ravishankar C, McCrindle BW, Williams RV, Altmann K, Ghanayem NS, Margossian R, Chung WK, Border WL, Pearson GD, Stylianou MP, Mital S, Pediatric Heart Network Investigators

Authors

Dudley Woodrow Benson MD Clinical Professor in the Pediatrics department at Medical College of Wisconsin
Peter C. Frommelt MD Professor in the Pediatrics department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Aldosterone
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Double-Blind Method
Enalapril
Endothelium, Vascular
Glomerular Filtration Rate
Heart Failure
Heart Ventricles
Humans
Infant
Stroke Volume
jenkins-FCD Prod-398 336d56a365602aa89dcc112f077233607d6a5abc