Enalapril (target dose - 0.4 mg/kg/day) vs. Placebo
Enrolled 230 infants with single ventricle physiology
Followed up to 14 months of age
Primary end point: Weight at 14 months
185 completed trial(Rest were lost to either withdrawal from trial or death/transplant - 13%)
Other measures: Height, Ross score, BNP, Bayley Scale of infant development & Ventricular ejection fraction.
Result: No difference between the two group in any of the parameters studied.
Death or Transplant occurred in 13% in either group.
Adverse reactions occurred in 88 of Enalapril group and 87 of Placebo group.
