Non-invasive Prediction of EArly Cardiac rEjection

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-25
SponsorVanderbilt University Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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*

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

200 Participants
are grouped into 3 trial groups

Sponsors and collaborators

Vanderbilt University Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator