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Randomized Controlled Trial
. 2009 Jan;157(1):37-45.
doi: 10.1016/j.ahj.2008.08.030.

Rationale and design of a trial of angiotensin-converting enzyme inhibition in infants with single ventricle

Daphne T Hsu  1 , Seema Mital, Chitra Ravishankar, Renee Margossian, Jennifer S Li, Lynn A Sleeper, Richard V Williams, Jami C Levine, Brian W McCrindle, Andrew M Atz, Darlene Servedio, Lynn Mahony; Pediatric Heart Network Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Rationale and design of a trial of angiotensin-converting enzyme inhibition in infants with single ventricle

Daphne T Hsu et al. Am Heart J. 2009 Jan.

Abstract

Background: Angiotensin converting enzyme (ACE) inhibitors are known to improve clinical outcome and ventricular function in adults with heart failure. Infants with single-ventricle physiology show abnormalities in ventricular function as well as poor growth. The ability of an ACE inhibitor to preserve ventricular function and improve growth in these infants is unknown.

Methods: The Pediatric Heart Network designed a randomized, double-blind trial to compare outcomes in infants with single-ventricle physiology receiving enalapril or placebo. Neonates < or =45 days old were eligible. The primary outcome is weight-for-age Z-score at 14 months of age. Secondary outcomes include other measures of somatic growth, laboratory and functional measures of heart failure, developmental indices, measures of ventricular size and function, and the relationship of the renin-angiotensin-aldosterone system genotype to the response to enalapril. The incidence and spectrum of adverse events will also be compared between treatment groups.

Results: A total of 1,245 neonates were screened and 533 (43%) were eligible. The consent rate was 43%; 230 subjects were enrolled. Parental reluctance to participate was the primary reason for non-consent in 79% of the eligible nonconsenting patients. Randomized patients were older, more likely to be male, and more likely to have hypoplastic left heart syndrome than the eligible patients who did not enroll.

Conclusions: The results of this randomized trial will make an important contribution to the management of infants with single-ventricle physiology by determining whether initiation of ACE inhibition therapy in the neonatal period improves growth, clinical outcome, and ventricular function.

Trial registration: ClinicalTrials.gov NCT00113087.

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Figures

Figure 1
Figure 1. Pediatric Heart Network Infant Single Ventricle Trial Protocol
SCPA=superior cavo-pulmonary anastomosis, HF = heart failure, BNP = B-type natriuretic peptide, Echo = echocardiogram
Figure 2
Figure 2
Preparation and Uptitration of Study Drug
Figure 3
Figure 3. Pediatric Heart Network Infant Single Ventricle Trial Screening Results
IV= intravenous, abs= absolute
See this image and copyright information in PMC

References

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