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The purpose of this multi-center study is to learn more about which anti-rejection medications best protect infants, children, adolescents, and young adults after they have had a heart transplant. Researchers hope to learn which medications are best at preventing rejection, and also which medications are best at preventing long-term problems after heart transplant, including kidney disease, infection, coronary artery disease, and post-transplant lymphoproliferative disease. Researchers will be comparing effectiveness of the current standard of care for pediatric heart transplant immunosuppression, a combination of the drugs tacrolimus (TAC) and mycophenalate mofetil (MMF), to another regimen using low-dose tacrolimus (LDTAC) and everolimus (EVL).
The study is enrolling people who were younger than 21 at the time of their heart transplant, providing that they show no sign of rejection at their 6-month post-surgery evaluation.
Males and Females: Patients who had a heart transplant at an age less than 21
Following screening participants will be randomly segmented into groups that will either take TAC plus MMF or LDTAC plus EVL. Participants will be seen by the study team for testing and evaluations every 3 months for 4 visits and again every 6 months thereafter for the final 3 visits.
Visits: 8 including screening
Duration: 30 months
U.S. Department of Defense
Boston Children’s Hospital
Study Description at National Institutes of Health
Brian Feingold, MD
For more information about the study, please contact:
Maggie Abraham, CCRC
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
UPMC Children’s Hospital of Pittsburgh
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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