Non-invasive Prediction of EArly Cardiac rEjection
PEACE
Predictive Modeling of Acute Rejection in Pediatric Heart Transplant Recipients
2 other identifiers
observational
200
1 country
22
Brief Summary
Acute rejection remains a major cause of morbidity and mortality in pediatric patients after heart transplant. In order to screen for rejection, most centers perform heart catheterizations with endomyocardial biopsies frequently in the first year post transplant and then every 1-2 years thereafter; these biopsies are associated with complications, can cause significant anxiety in patients and family members, and are a significant cost for the healthcare system. This project will evaluate non-invasive methods of detecting rejection using cardiac magnetic resonance imaging and blood testing with a goal to reduce the required number of cardiac catheterizations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2023
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2023
CompletedFirst Submitted
Initial submission to the registry
August 12, 2026
CompletedFirst Posted
Study publicly available on registry
August 18, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
August 20, 2026
June 1, 2026
3.8 years
August 12, 2026
August 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute rejection
Rejection is defined as a clinical event that results in augmentation of immunosuppression. Core pathology laboratory will determine biopsy positive vs biopsy negative rejection.
time of enrollment
Study Arms (3)
Healthy pediatric heart transplant recipients
Pediatric heart transplant recipients not having rejection
Pediatric heart transplant recipients with acute rejection
Pediatric heart transplant recipients with acute rejection (ACR or AMR) as defined by the the core pathologist.
Healthy controls
Healthy control patients retrospectively enrolled at each site to standardize parametric mapping.
Eligibility Criteria
Pediatric heart transplant recipients undergoing endomyocardial biopsy either for concerns of rejection or for routine surveillance.
You may qualify if:
- Received heart transplant at age \< 21 years old
- \> 2 months from transplant
- ≥6 years old and ≤ 25 years old and able to undergo cardiac MRI (CMR)
- CMR can be scheduled within 5 days from heart biopsy\*
- Heart catheterization with biopsy is scheduled "for cause" to confirm suspected AR or Heart catheterization with biopsy is scheduled for surveillance
You may not qualify if:
- No endomyocardial biopsy scheduled
- Other illness or disease process that could potentially lead to myocardial edema or fibrosis
- Contraindication to CMR with contrast
- Previously enrolled in this study, UNLESS previous enrollment was heart biopsy scheduled for surveillance with no suspicion of AR AND final study status was documented as "no AR" AND current enrollment is heart biopsy is scheduled "for cause" to confirm suspected AR
- Multiple transplanted organs
- Requires anesthesia for CMR
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
UCLA
Los Angeles, California, 90095, United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304, United States
Rady Children's Hospital
San Diego, California, 92123, United States
Children's Hospital Colorado
Denver, Colorado, 13123, United States
University of Florida
Gainesville, Florida, 32608, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Children's Hospital of Atlanta
Atlanta, Georgia, 30322, United States
Lurie Children's Hospital
Chicago, Illinois, 02115, United States
Riley Children's Hospital
Indianapolis, Indiana, 46202, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Washington University
St Louis, Missouri, 63110, United States
Mount Sinai Kravis Children's Hospital
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
UT Health Houston
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Biospecimen
blood, cell free DNA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 12, 2026
First Posted
August 18, 2026
Study Start
March 29, 2023
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
August 20, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Study conclusion
- Access Criteria
- We will honor requests for sharing of requested data for non-profit research purposes.