Impact of Allo- and Autoantibodies on Chronic Cardiac Allograft Function

Completed

Conditions studied: Pediatric Heart Transplantation, Pediatric Heart Transplant Recipients

In brief

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.

Key facts

Study ID

NCT02752789

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

407

Starts

2014-07-15

Expected to finish

2019-11-01

Last updated by the study team

2019-11-29

Who can join

Age: any, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject and/or parent guardian able to understand and provide informed consent and where applicable assent
• Planned long-term follow-up at one of the study sites
• AND either:
• Enrolled in the CTOTC-04 study and actively followed at one of the study sites
• OR
• Listed at participating study sites, less than 21 years of age and not yet transplanted.
• The inclusion criteria for enrollment of new study patients in the CTOTC-09 Protocol will be the same as the CTOTC-04 study (refer to ClinicalTrials.gov ID NCT01005316).

You may not qualify if…

• Parental withdrawal of consent from the CTOTC-04 study
• Past or current medical problems or findings from physical examination or laboratory testing that, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study
• Listed for simultaneous multiple organ transplant.

Where it is running

• Emory University School of Medicine — Atlanta, Georgia, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Children's Hospital at Montefiore — New York, New York, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Monroe Carell Jr. Children's Hospital — Nashville, Tennessee, United States
• Hospital for Sick Children — Toronto, Canada

Full record on ClinicalTrials.gov

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