NCT07770659 · Vanderbilt University Medical Center
Non-invasive Prediction of EArly Cardiac rEjection
(PEACE)
What this study is about
Acute rejection remains a major cause of morbidity and mortality in pediatric patients after heart transplant.
View original scientific description
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.
Primary outcome measures
Acute rejection
Time frame: time of enrollment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Little Rock, Arkansas
- Los Angeles, California
- Palo Alto, California
- San Diego, California
- Denver, Colorado
- Gainesville, Florida
- Hollywood, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Indianapolis, Indiana
- Boston, Massachusetts
- Ann Arbor, Michigan
And 7 more locations — see the full list below.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 18, 2026 · Source of record for eligibility and locations