Phase 3
N=230
Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network
Heart Defects, Congenital · Heart Failure, Congestive
Bottom Line
View on ClinicalTrials.gov: NCT00113087 ↗Enrolled (actual)
230
Serious AEs
76.1%
Results posted
Sep 2010
Primary outcome: Primary: Weight-for-age Z-score at 14 Months of Age — -0.62; -0.42 standard deviation — p=0.28
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Enalapril (Drug); Placebo (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight-for-age Z-score at 14 Months of Age |
-0.62; -0.42 | 0.28 |
| SECONDARY Height-for-age Z-score |
-1.00; -0.86 | 0.42 |
| SECONDARY Head Circumference-for-age Z-score |
-0.55; 0.09 | 0.008 sig |
| SECONDARY Number of Participants With Ross Heart Failure Class I |
72; 77 | 0.71 |
| SECONDARY Number of Participants With Ross Heart Failure Class I |
72; 77 | 0.71 |
| SECONDARY B-Type Natriuretic Peptide |
79; 84 | 0.74 |
| SECONDARY B-type Natriuretic Peptide Level |
25; 39 | 0.22 |
| SECONDARY Neurodevelopmental Status (PDI): the Bayley Scales of Infant Development,Psychomotor Development Index Z-score |
-1.29; -1.32 | 0.86 |
| SECONDARY Neurodevelopmental Status(MDI): Bayley Scales of Infant Development, Mental Developmental Index Z-score |
-0.26; -0.33 | 0.60 |
| SECONDARY Neurodevelopmental Status (FSII) |
96.4; 96.4 | 0.60 |
| SECONDARY MacArthur-Bates Inventory -Phrases Understood |
-0.48; -0.92 | 0.01 sig |
| SECONDARY MacArthur-Bates Inventory -Words Understood |
-0.46; -0.82 | 0.008 sig |
| SECONDARY MacArthur-Bates Inventory -Total Gestures |
-0.86; -1.31 | 0.004 sig |
| SECONDARY MacArthur-Bates Inventory -Words Produced |
-0.60; -0.63 | 0.31 |
| SECONDARY Ejection Fraction (%) |
59.3; 57.9 | 0.37 |
| SECONDARY Ejection Fraction (%) |
59.3; 57.9 | 0.37 |
| SECONDARY Ventricular Mass |
31.4; 34.4 | 0.07 |
| SECONDARY Ventricular Mass |
31.4; 34.4 | 0.07 |
| SECONDARY Ventricular Mass Z-score |
2.5; 3.1 | 0.11 |
| SECONDARY Ventricular Mass Z-score |
2.5; 3.1 | 0.11 |
| SECONDARY End-diastolic Volume |
29.2; 30.7 | 0.35 |
| SECONDARY End-diastolic Volume |
29.2; 30.7 | 0.35 |
| SECONDARY End Diastolic Volume Z-score |
2.3; 2.1 | 0.62 |
| SECONDARY End-diastolic Volume Z-score |
1.1; 1.3 | 0.43 |
| SECONDARY Ventricular Mass to Volume Ratio |
1.14; 1.20 | 0.34 |
| SECONDARY Ventricular Mass to Volume Ratio |
1.14; 1.20 | 0.34 |
| SECONDARY Ventricular Filling Pressure |
10.9; 11.1 | .81 |
| SECONDARY Number of Participants With Moderate to Severe AV Valve Regurgitation |
11; 22 | 0.06 |
| SECONDARY Number of Participants With Moderate to Severe AV Valve Regurgitation |
11; 22 | 0.06 |
Summary
This study will evaluate the efficacy and safety of administering an angiotensin converting enzyme inhibitor (ACE-I) (enalapril) to infants with a functional single ventricle. The study will also compare the effect of ACE-I therapy to placebo on somatic growth and compare the effect of ACE-I therapy to placebo on signs and symptoms of heart failure, neurodevelopmental and functional status, ventricular geometry, function, and atrioventricular (AV) valve regurgitation. In addition, the study will determine the relationship between genetic polymorphisms linked to ventricular hypertrophy (enlarged heart) and the response to ACE-I therapy and compare the incidence of adverse events in subjects treated with ACE-I with those in subjects treated with placebo.
Eligibility Criteria
Inclusion Criteria
- Less than or equal to 45 days of age
- Age greater than 1 week if born at 35 weeks gestation
- Single ventricle physiology
- Stable systemic and pulmonary blood flow
- Planned Glenn shunt surgery (or variant known as hemi-Fontan)
Exclusion Criteria
- Birth weight less than or equal to 2.5 kg if gestational age is greater than or equal to 38 weeks
- Birth weight less than the 10th percentile for gestational age if gestational age is 35 to 37 weeks
- Less than 35 weeks gestation
- Anatomic diagnosis of pulmonary atresia with intact ventricular septum
- Less than 3 days after palliative cardiac surgical procedure, if performed
- Aortic oxygen saturation less than 65%
- Current mechanical ventilatory support
- Current intravenous inotropic support
- Creatinine greater than 1.0 mg/dL
- Absolute neutrophil count less than 1, 000 cells/mL
- Chromosomal or recognizable phenotypic syndrome of noncardiac congenital abnormalities associated with growth failure (e.g., Trisomy 21, Noonan's syndrome, Turner's syndrome)
- Prior ACE inhibitor use for greater than 7 consecutive days
Data sourced from ClinicalTrials.gov (NCT00113087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.