CompletedNot Applicable

Impact of Allo- and Autoantibodies on Chronic Cardiac Allograft Function

United States407 participantsStarted 2014-07-15

Plain-language summary

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.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓Enrolled in the CTOTC-04 study and actively followed at one of the study sites
✓Listed at participating study sites, less than 21 years of age and not yet transplanted.

What they're measuring

Pulmonary capillary wedge pressure at heart catheterization

Timeframe: 3 years post-transplantation

Trial details

NCT IDNCT02752789

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2019-11-01

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