At a glance
ClinicalIndex Comparison Record- ✓Age ≤45 days
- ✓Age >1 week if born at 35 weeks gestation or later
- ✓Single ventricle physiology
- ✓Stable systemic and pulmonary blood flow
- ✕Birth weight ≤2.5 kg if gestational age ≥38 weeks
- ✕Birth weight <10th percentile for gestational age if 35–37 weeks
- ✕Gestational age <35 weeks
- ✕Pulmonary atresia with intact ventricular septum
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Trial of ACE Inhibition in Infants With Single Ventricle (A Trial Conducted by the Pediatric Heart Network)
In Brief
A Phase 3 clinical trial evaluating Enalapril and Placebo for Heart Defects, Congenital and Heart Failure, Congestive. Completed, enrolled 230 participants across 9 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Enalapril to target dose of .4mg/kg/day divided to twice per day (BID)
Participants will receive placebo