Status:
COMPLETED
Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsors:
Pediatric Heart Network
Conditions:
Heart Defects, Congenital
Heart Failure, Congestive
Eligibility:
All Genders
Up to 45 years
Phase:
PHASE3
Brief 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 comp...
Detailed Description
BACKGROUND: Growth impairment is common in infants and children with congenital heart disease, most often in the presence of congestive heart failure and/or cyanosis. Growth failure is noted in many ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00113087
Start Date
August 1 2003
End Date
July 1 2008
Last Update
September 28 2010
Active Locations (9)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
2
Columbia College of Physicians and Surgeons
New York, New York, United States, 10032
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229