The purpose of this study will be to evaluate the effectiveness and safety of human growth hormone(hGH) administration in children and adolescents who have had heart transplants and are failing to grow normally. hGH is currently approved for use by the FDA for children with growth hormone deficiency (GHD) and we will be giving it only to those heart transplant patients who are exhibiting growth failure. All enrolled patients will receive the study treatment of hGH at the same dose based on body weight. Each patient will serve as his own control based on a pre-treatment observation of 12-18 months. The study will involve the daily subcutaneous administration of hGH to the patient and the careful monitoring of both growth and possible side effects. The monitoring aspect will be included in the routine every-three-month follow-up that all pediatric transplant patients undergo. These visits include extensive cardiologic testing (including a cardiac biopsy), blood tests, x-rays and a full physical exam.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000645-29
Application #
6413258
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1977-12-01
Project End
2004-11-30
Budget Start
Budget End
Support Year
29
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Columbia University (N.Y.)
Department
Type
DUNS #
167204994
City
New York
State
NY
Country
United States
Zip Code
10032
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