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

This trial does not accept healthy volunteers

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 population

Pediatric heart transplant recipients undergoing endomyocardial biopsy either for concerns of rejection or for routine surveillance.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 3 trial groups
Group A: Healthy pediatric heart transplant recipients
Group B: Pediatric heart transplant recipients with acute rejection
Group C: Healthy controls

Trial outcomes

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 frame
time of enrollment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator