Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network (ISV)
Heart Defects, Congenital, Heart Failure, Congestive
About this trial
This is an interventional treatment trial for Heart Defects, Congenital
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
Sites / Locations
- Children's Hospital Boston
- Columbia College of Physicians and Surgeons
- Duke University Medical Center
- Cincinnati Children's Hospital Medical Center
- Children's Hospital of Philadelphia
- Medical University of South Carolina
- Primary Children's Hospital
- Children's Hospital of Wisconsin
- Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Enalapril
Placebo
Enalapril (angiotensin converting enzyme inhibitor)
Placebo (Ora-Plus and Ora-Sweet)