Pediatric Heart Transplantation Clinical Trial
Official title:
An Observational Cohort Study to Determine the Impact of Alloantibodies and Antibodies to Self Antigens on Chronic Graft Function up to 5 Years After Pediatric Heart Transplantation (CTOTC-09)
This is a multi-center, prospective, single cohort, observational study of pediatric heart transplant recipients designed to determine the impact of preformed versus de novo human leukocyte antigen (HLA) donor-specific antibodies (DSA), and antibodies to the self-antigens cardiac myosin and vimentin, on chronic allograft function. In addition, the investigators will explore mechanisms of action and predictors of DSA, rejection and altered pathophysiology.
Participants that were enrolled in the CTOTC-04 study (ClinicalTrials.gov Identifier
NCT01005316) are invited to enroll in this CTOTC-09 study. Conversion from the CTOTC-04 to
CTOTC-09 study will occur in such a manner as to avoid/minimize discontinuity of follow-up
between the planned CTOTC-04 and CTOTC-09 study visits. In addition, subjects added to the
United Network for Organ Sharing (UNOS) system-or Canadian equivalent agency-at a
participating study site, who are less than 21 years of age and fulfill all study eligibility
criteria, will be invited to enroll in CTOTC-09.
This study focuses on the importance of antibodies against the newly transplanted heart in
pediatric heart transplant recipients. The investigators aim to determine if certain
antibodies lead to problems with the heart transplant. Antibodies are small proteins in the
blood that the body makes to fight off infections, for example with bacteria or viruses.
Since a new heart is "foreign" to the recipient's body, their immune system might try to
attack it with antibodies, as if it were an infection. For many years it was thought that
only white blood cells attacked the new heart, causing rejection.
Now there is new information showing that antibodies may also cause rejection or long-term
damage to the heart. At this time, very little is known about how antibodies might cause
problems after heart transplantation in transplant recipients younger than 21 years at the
time of transplant.
This study will collect a medical history and blood samples at specified times for research.
The blood samples will be used to measure antibodies in the blood, and to perform special
tests to see how these antibodies might damage the heart.
Participant follow-up is from the day of the heart transplant to year 5 post-transplant.
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Status | Clinical Trial | Phase | |
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Allo-Antibodies in Pediatric Heart Transplantation
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Completed |
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