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

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.

Conditions

• Heart Defects, Congenital
• Heart Failure, Congestive

Interventions

DRUG

Enalapril

Enalapril to target dose of .4mg/kg/day divided to twice per day (BID)

DRUG

Placebo

Participants will receive placebo

Sponsors & Collaborators

• Pediatric Heart Network

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  lead NIH

Principal Investigators

• Page Anderson, MD · Duke University Medical Center, Durham, NC

• Daphne Hsu, MD · The Children's Hospital at Montefiore, NYC, NY

• Brian McCrindle, MD · The Hospital for Sick Children

• LuAnn Minich, MD · Primary Children's Hospital, Salt Lake City, UT

• Jane Newburger, MD · Children's Hospital Boston, Boston, MA

• J. Philip Saul, MD · Medical University of South Carolina

• Lynn Sleeper, Sc.D. · New England Research Institute, Watertown, MA

• Victoria Vetter, MD · Children's Hospital of Philadelphia, Philadelphia, PA

• Woodrow Benson, MD · Cincinnati Children's Medical Center, Cincinnati, OH

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Max Age

45 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-08-31

Primary Completion

2008-07-31

Completion

2008-07-31

Countries

• United States
• Canada

Study Locations