Non-invasive Prediction of EArly Cardiac rEjection (NCT07770659)
Predictive Modeling of Acute Rejection in Pediatric Heart Transplant Recipients
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (7 items).
Location: Arkansas Children's Hospital — Little Rock, Arkansas
Age range: 6 Years to 25 Years
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (22 Sites)
- Arkansas Children's Hospital — Little Rock, Arkansas
- Children's Hospital of Los Angeles — Los Angeles, California
- UCLA — Los Angeles, California
- Lucile Packard Children's Hospital at Stanford — Palo Alto, California
- Rady Children's Hospital — San Diego, California
- Children's Hospital Colorado — Denver, Colorado
- University of Florida — Gainesville, Florida
- Joe DiMaggio Children's Hospital — Hollywood, Florida
- Children's Hospital of Atlanta — Atlanta, Georgia
- Lurie Children's Hospital — Chicago, Illinois
- Riley Children's Hospital — Indianapolis, Indiana
- Boston Children's Hospital — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Washington University — St Louis, Missouri
- Mount Sinai Kravis Children's Hospital — New York, New York
- Columbia University — New York, New York
- Nationwide Children's Hospital — Columbus, Ohio
- Vanderbilt University Medical Center — Nashville, Tennessee
- Texas Children's Hospital — Houston, Texas
- UT Health Houston — Houston, Texas
- Seattle Children's Hospital — Seattle, Washington
- Medical College of Wisconsin — Milwaukee, Wisconsin
📞 Contact the Study Coordinator
Phone: (615) 322-7447
Email: PEACE@vumc.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Heart Transplant
- XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP) — La Jolla, California
- US National OCS Heart Perfusion (OHP) Registry — Phoenix, Arizona
- Randomized Trial of SGLT2i in Heart Transplant Recipients — Palo Alto, California
- Belatacept in Heart Transplantation — Los Angeles, California
- OCS DCD Heart + CAP Continued Follow-Up — La Jolla, California
Explore by condition: All Heart Transplant clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.