Hemodynamic and clinical effects of enalapril in management of children with congestive heart failure : a randomized, placebo-controlled study

Objective: To assess hemodynamic and clinical effects of Enalapril in treating children with congestive heart failure and possible side effects of Enalapril in pediatric population. Design: A randomized placebo controlled clinical study. Setting: Children’s Hospital of Shanghai Medical University. Patients: Eighty-four consecutive children diagnosed with congestive heart failure were stratified into 2 strata according to whether congestive heart failure was caused by congenital heart disease or by impaired systolic function. Within each stratum, patients were randomly assigned into the Enalapril + conventional therapy (Enalapril group n=42) or placebo + conventional group (controlled group, n=42). Intervention: Both group at least had conventional therapy 48 hours before study started. Enalapril group then were added Enalapril from 0.1 ma/kg/day (day 1): 0.15 mg/kg/day (day2) to 0.25 mg/kg/day. Dosage at 0.25 mg/kg/day maintained while patients were tolerated during the study. Patients in controlled group continued their conventional therapy plus placebo. Results: After two weeks treatment both group showed a significant improvement in their cardiac contractility and clinical symptoms and signs. Cardiac contractility index increased significantly. And heart rate, respiratory rate, liver size decreased significantly within each group after treatment (p<0.05) Enalapril group had an additional achievement to compare with controlled group. Enalapril group showed a further improvement of increasing 22%(95% CI: 3%-41%) more patients whose cardiac contractility had been back to normal range. Enalapril group also showed a significant additional improvement of increasing VCFc, reducing heart rate, respiratory rate, live size compared with controlled group. Though significant reduction of cardiacthoracic ratio and gaining body weight did happen in enalapril group, but statistically no difference when compared with the controlled group. No severe side effects had been found during study period. Sodium, potassium slightly increased and creatinine, urea slightly decreased after treatment in both groups. Blood pressure dropped mildly with no significant difference within and between group. Conclusion: Enalapril in conjunction with conventional therapy in treating children with congestive heart failure can provide additional hemodynamic and clinical improvements compared with conventional therapy alone. In order to evaluate its long term effects and economic impact, a further long term clinical trial is necessary.