Impact of Allo- and Autoantibodies on Chronic Cardiac Allograft Function
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)
1 other identifier
observational
407
2 countries
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2014
CompletedFirst Submitted
Initial submission to the registry
April 22, 2016
CompletedFirst Posted
Study publicly available on registry
April 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedNovember 29, 2019
November 1, 2019
5.3 years
April 22, 2016
November 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pulmonary capillary wedge pressure at heart catheterization
3 years post-transplantation
Secondary Outcomes (16)
Other invasive cardiac hemodynamic findings at cardiac catheterization
3 and 5 years post-transplantation
Frequency of development of post-transplant de novo DSA and autoantibodies to cardiac myosin and vimentin
3 years post-transplantation
Time course of development of post-transplant de novo DSA and autoantibodies to cardiac myosin and vimentin.
3 years post-transplantation
Frequency of first episode of late acute rejection
From >1 year to 5 years post-transplantation
Time to first episode of late acute rejection
From >1 year to 5 years post-transplantation
- +11 more secondary outcomes
Other Outcomes (4)
Exploratory: Microvascular pathology
Up to 5 years post-transplantation
Exploratory: Expression of cytoprotective genes Bcl2 and HO-1, ICAM, VCAM and selectins, Complement inhibitory proteins CD55, CD59, CR1, CR2 and CR3.
After exposure to alloantibody (or control) (At Year 1)
Exploratory: Cellular immune responses to allo-antigens and self-antigens (vimentin and myosin)
24 hours prior transplantation, Months 3 and 6 post transplantation
- +1 more other outcomes
Study Arms (1)
Pediatric Heart Transplant Recipients
CTOTC-04 (ClinicalTrials.gov ID NCT01005316) participants who consent to long-term follow-up as part of this study as well as candidates less than 21 years of age who are listed for isolated orthotopic heart transplantation at one of the participating sites
Eligibility Criteria
Participants that were enrolled in CTOTC-04 (ClinicalTrials.gov ID NCT01005316) who consent to long-term follow-up and new participants at the nine designated sites who are listed for isolated orthotopic heart transplantation
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
- Listed at participating study sites, less than 21 years of age and not yet transplanted.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Emory University School of Medicine
Atlanta, Georgia, 30060, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Columbia University Medical Center
New York, New York, 10032, United States
Children's Hospital at Montefiore
New York, New York, 10467, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Monroe Carell Jr. Children's Hospital
Nashville, Tennessee, 37232, United States
Hospital for Sick Children
Toronto, M5G 1X8, Canada
Related Links
Biospecimen
Whole blood, plasma, PBMC and tissue
Study Officials
- STUDY CHAIR
Steven A. Webber, MBChB, MRCP
Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation
- PRINCIPAL INVESTIGATOR
Steven A. Webber, MBChB, MRCP
Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2016
First Posted
April 27, 2016
Study Start
July 15, 2014
Primary Completion
November 1, 2019
Study Completion
November 1, 2019
Last Updated
November 29, 2019
Record last verified: 2019-11