Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Collaborator: Pediatric Heart Network
• Treatments: Enalapril; Enalaprilat

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