This study will evaluate the efficacy and safety of administering ACE-I (enalapril) to infants with a functional single ventricle.

Primary Outcome: To compare the effect of ACE-I therapy to placebo on somatic growth Secondary Outcomes: To compare the effect of ACE-I therapy to placebo on signs and symptoms of heart failure, neurodevelopmental and functional status, ventricular geometry, function and AV valve regurgitation. To determine the relationship between genetic polymorphisms linked to ventricular hypertrophy (enlarged heart) and the response to ACE-I therapy. To compare the incidence of adverse events in subjects treated with ACE-I compared to those subjects receiving placebo.

Condition	Treatment or Intervention	Phase
Defect, Congenital Heart Heart Failure, Congestive	Drug: Enalapril	Phase III

Further Study Details: 

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 infants with single ventricle who manifest both cyanosis and heart failure which commonly persists after palliative surgery. Whether this impairment is related to persistent or progressive abnormalities in cardiac structure and function is not known. Angiotensin converting enzyme inhibitors (ACE-I) are widely used in the treatment of infants with severe congestive heart failure to improve cardiac function and somatic growth. The ability of an ACE-I to improve somatic growth in infants with single ventricle has not been previously studied.

This study has been approved by the Institutional Review Boards/Research Ethics Boards of all participating clinical centers: Hospital for Sick Children, Toronto, Canada Children''''s Hospital Boston, Boston, MA Columbia College of Physician and Surgeons, NY, NY Children''''s Hospital of Philadelphia, Philadelphia, PA Duke University Medical Center, Durham, NC Brody School of Medicine at East Carolina University, Greenville, NC Wake Forest Baptist Medical Center, Winston Salem, NC Medical University of South Carolina, Charleston, SC Primary Children''''s Medical Center, Salt Lake City, UT Children''''s Hospital of Wisconsin, Milwaukee, WI University of Michigan, Ann Arbor, MI Cincinnati Children''''s Hospital Medical Center, Cincinnati, OH

DESIGN NARRATIVE: This is a prospective, randomized, double-blind, placebo-controlled trial of ACE-I in infants with single ventricle. After stratification by ventricular anatomy, neonates will be randomly assigned to receive enalapril or placebo and then followed for 14 months.

Genders Eligible for Study:  Both

Criteria

Less than or equal to 45 days of age Age > 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)

Please refer to this study by ClinicalTrials.gov identifier  NCT00113087

Massachusetts
      Children''''s Hospital Boston, Boston,  Massachusetts,  02115,  United States; Recruiting
New York
      Columbia College of Physicians and Surgeons, New York,  New York,  10032,  United States; Recruiting
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting
Pennsylvania
      Children''''s Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting
Utah
      Primary Children''''s Hospital, Salt Lake City,  Utah,  84113,  United States; Recruiting
Canada, Ontario
      Hospital for Sick Children, Toronto,  Ontario,  M5G 1X8,  Canada; Recruiting

Study chairs or principal investigators

Page Anderson,  Duke University   
Welton Gersony,  Columbia College of Physicians and Surgeons   
Brian McCrindle,  The Hospital for Sick Children   
LuAnn Minich,  Primary Children''''s Hospital   
Jane Newburger,  Children''''s Hospital Boston   
J. Saul,  Medical University of South Carolina   
Lynn Sleeper,  New England Research Institute   
Victoria Vetter,  Children''''s Hospital of Philadelphia   

Study ID Numbers:  177
Record last reviewed:  May 2005
Last Updated:  June 3, 2005
Record first received:  June 3, 2005
ClinicalTrials.gov Identifier:  NCT00113087
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-06-07