Non-invasive test to predict early heart rejection in pediatric transplant patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project investigates whether advanced non-invasive techniques, including cardiac MRI with parametric mapping and blood-based biomarkers such as donor-derived cell-free DNA, can detect acute rejection in pediatric heart transplant recipients. The study aims to combine imaging and blood tests to identify rejection earlier and more safely, possibly reducing the frequency of endomyocardial biopsies. Enrollment includes patients up to age 25 who recently had a transplant and are scheduled for biopsy either for cause or surveillance. Analyses will consider spatial patterns in MRI data rather than global averages to improve diagnostic accuracy. The lead sponsor is Vanderbilt University Medical Center, with NHLBI collaboration and sites in Arkansas and California.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

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

Where it's running

• Arkansas Children's Hospital
  Little Rock, Arkansas, United States Recruiting
• Children's Hospital of Los Angeles
  Los Angeles, California, United States Recruiting
• UCLA
  Los Angeles, California, United States Recruiting
• Lucile Packard Children's Hospital at Stanford
  Palo Alto, California, United States Recruiting
• Rady Children's Hospital
  San Diego, California, United States Recruiting
• Children's Hospital Colorado
  Denver, Colorado, United States Recruiting

Study contacts

• Study coordinator: Jonathan Soslow, MD MSCI
• Email: PEACE@vumc.org
• Phone: 615-322-7447

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.