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

Completed · Phase 3 · Has a placebo group

Conditions studied: Heart Defects, Congenital, Heart Failure, Congestive

In brief

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.

Key facts

Study ID

NCT00113087

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

230

Starts

2003-08-01

Expected to finish

2008-07-01

Last updated by the study team

2010-09-28

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States
• Columbia College of Physicians and Surgeons — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
• Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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