Infant Single Ventricle – ISV was a trial testing a medication in infants after surgery for single ventricle.
This study was done to see if giving a medication called Enalapril (an ACE inhibitor) would improve a baby’s growth and heart function in the first year of life. The study began on August 25, 2003 and the last infant was enrolled in May 2007 with 230 babies enrolled.
The study began on August 25, 2003 and the last infant was enrolled in May 2007
Were enrolled in this study
Enalapril did not provide a benefit for a baby’s growth, heart function, or development at 14 months of age
Each qualified child was randomly assigned to one of two treatment groups. One group received Enalapril and the other group received a placebo. Babies were followed until they reached 14 months of age.
The ACE inhibitor medication called Enalapril did not provide a benefit for a baby’s growth, heart function, or development at 14 months of age.
What we learned may or may not apply to a specific child. These findings are based on all 230 children, and individual results may be different.
The PHN is grateful to all of the families who participated in this study. The results from this study has helped us to learn more about improving the care of children with a single ventricle heart defect. The Pediatric Heart Network plans to use these results to design additional studies in the near future.
D. Hsu, Circulation 2010; 122:333-340.
D. Hsu, Am Heart J 2009; 157:37-45.
Angiotensin-converting enzyme (ACE) inhibitors are medicines that improve heart function in adults with heart failure. Infants with a particular type of congenital heart defect (known as single ventricle) have been shown to have abnormal heart function and poor growth. This study was designed to determine if giving ACE inhibitors to babies with single-ventricles would improve their growth, heart function and development. This article describes the design, the participants and the procedures of this trial.
R. Williams, Congenit Heart Dis 2010; 5:96-103.
Many congenital heart defects are associated with low birth weight and prematurity, but there is little information on birth characteristics of babies with a specific kind of defect, single ventricle physiology. This study compares birth parameters for babies enrolled in the Infant Single Ventricle Trial as compared to the typical US population. Infants with single ventricle had increased rates of preterm birth and low birth weight, and they were more likely to be small for gestational age than the general population.
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R. Williams, J Pediatr 2011; 159:1017-22.
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C. Ravishankar, J Pediatr 2013; 162(2): 250–256.e2.
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I. Williams, Am Heart J 2013; 165(4):544-550.e1.
A. S. Carey, Circ Cardiovasc Genet. 2013 Oct; 6(5): 444–451.
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