Table 3. Secondary Outcomes by Treatment Assignment.
| Pre-SCPC Surgery | Final-study visit | |||||
|---|---|---|---|---|---|---|
| Variable | Enalapril | Placebo | P Value* | Enalapril | Placebo | P Value* |
| BNP (pg/ml) | ||||||
| Median (no. of patients) | 79.0 (83) | 84.0 (90) | 0.74 | 25.0 (69) | 39.0 (65) | 0.22 |
| IQR | 30-182 | 36-196 | 13-55 | 21-86 | ||
| mean±SD (no. of patients) | mean±SD (no. of patients) | |||||
| Ejection Fraction (%) | 57.9±9.8 (94) | 56.6±10.2 (95) | 0.36 | 59.3±9.6 (87) | 57.9±10.4 (91) | 0.37 |
| Ventricular mass (g) | 25.5±9.2 (93) | 28.1±10.6 (94) | 0.08 | 31.4±10.3 (87) | 34.4±11.4 (89) | 0.07 |
| Ventricular mass z-score | 4.0±2.9 (92) | 4.9±3.3 (92) | 0.05 | 2.5±2.3 (87) | 3.1±2.5 (89) | 0.11 |
| End-diastolic volume (ml) | 24.1±10.1 (94) | 23.2±9.0 (95) | 0.49 | 29.2±10.0 (87) | 30.7±11.3 (91) | 0.35 |
| End-diastolic volume z-score | 2.3±2.5 (93) | 2.1±2.5 (93) | 0.62 | 1.1±2.1 (87) | 1.3±2.4 (91) | 0.43 |
| Mass:volume ratio | 1.15±0.43 (93) | 1.31±0.50 (94) | 0.02 | 1.14±0.38 (87) | 1.20±0.44 (89) | 0.34 |
| Mass:volume ratio z-score† | 1.6±2.8 (93) | 2.6±3.2 (94) | 0.02 | 1.5±2.5 (87) | 1.9±2.9 (89) | 0.34 |
| Ventricular filling pressure (mmHg) |
10.9±3.6 (58) | 11.1±4.0 (63) | 0.81 | |||
| no./total no. (%) | no./total no. (%) | |||||
| Ross Heart Failure class I | 53/96 (55) | 56/102 (55) | 1.00 | 72/91 (79) | 77/94 (82) | 0.71 |
| Moderate to severe AV valve regurgitation |
20/98 (20) | 32/98 (33) | 0.08 | 11/90 (12) | 22/93 (24) | 0.06 |
| Bayley Scales of Infant Development, 2nd edition | ||||||
| mean±SD (no. of patients) | ||||||
| Mental Developmental Index z-score | −0.26±0.91 (87) | −0.33±1.02 (83) | 0.60 | |||
| Psychomotor Developmental Index z-score | −1.29±1.19 (86) | −1.32±1.22 (83) | 0.88 | |||
| Total Behavior Rating Scale | ||||||
| Median (no. of patients) | 58.0 (87) | 49.0 (82) | 0.19 | |||
| IQR | 29-83 | 23-71 | ||||
| Functional Status II(Revised) Total Score | ||||||
| Median | 96.4 (89) | 96.4 (89) | 0.60 | |||
| IQR | 89-100 | 86-100 | ||||
| MacArthur-Bates Communicative Development Inventory (Words and Gestures) | ||||||
| Phrases Understood z-score | −0.48±1.11 (90) | −0.92±1.17 (87) | 0.01 | |||
| Words Understood z-score | −0.46±0.91 (90) | −0.82±0.83 (87) | 0.008 | |||
| Total Gestures z-score | −0.86±1.07 (90) | −1.31±0.97 (87) | 0.004 | |||
| Words Produced z-score | 0.31 | |||||
| Median (no. of patients) | −0.60 (90) | −0.63 (87) | ||||
| IQR | −0.72 to 0.41 | −0.75 to 0.42 | ||||
The P values for categorical variables were calculated with the use of a Fisher exact test. P values for variables presented as means and medians were calculated using a two-sample t-test and a Wilcoxon rank-sum test, respectively. The P value for BNP is calculated using a two-sample t-test of the natural logarithm of BNP.
Mass:volume ratio z-score was slightly skewed. Medians for the enalapril and placebo groups were 1.00 vs. 2.05 (Wilcoxon P=0.03), respectively, at pre-SCPC Surgery. Mass:volume ratio z-score medians for the enalapril and placebo groups were 0.96 vs. 1.10 (Wilcoxon P=0.57), respectively, at the final-study visit.
AV- atrioventricular valve; BNP- brain natriuretic peptide; IQR- interquartile range; no.- number of patients; SCPC- superior cava pulmonary connection.
Note. The one-sample t-test and Wilcoxon signed-rank test were used to compare the distribution of the Bayley Scales of Infant Development and MacArthur Communicative Development Inventory z-scores from the trial (presented in Table 3) with the normal population. These z-scores differ from zero (P<0.02). The Bayley Total Behavior Rating Scale percentile did not differ from the 50th percentile in either treatment arm. All echocardiographic z-scores differ from zero (P<0.01).