Non-invasive Prediction of EArly Cardiac rEjection (PEACE)

August 17, 2026 updated by: Jonathan Soslow, Vanderbilt University Medical Center

Predictive Modeling of Acute Rejection in Pediatric Heart Transplant Recipients

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Despite significant advances in the care of pediatric heart transplant (PHTx) patients, acute rejection (AR) remains one of the leading causes of death. Cardiac catheterization with endomyocardial biopsy (biopsy) is the standard of care for diagnosing AR and is performed when there is a clinical suspicion for AR or during routine surveillance. Unfortunately, biopsy is invasive and associated with potential risks, including: complications from anesthesia or sedation, valve damage, injury to the conduction system, vascular damage or occlusion, and cardiac perforation. These potential complications are magnified in the pediatric population. Non-invasive methods of detecting AR, such as blood biomarkers and cardiac magnetic resonance imaging (CMR), could decrease the frequency of biopsy. Blood biomarkers, such has donor fraction cell-free DNA and microRNA, have shown potential for diagnosis of AR but have not yet gained widespread adoption in PHTx. Advanced CMR parametric mapping sequences quantify myocardial fibrosis and edema, and our preliminary data suggest a potential for these sequences to diagnose AR. While CMR parametric mapping has significant promise, focusing simply on the average properties across an entire left ventricular plane or region ignores the spatial patterns of disease, resulting in a loss of information and an impaired ability to use the imaging data to direct care. Here we propose advanced image analysis methods that are more granular than plane analysis, including texture analysis, as a means for objectively analyzing different patterns of myocardial disease and developing predictive models that would allow improved clinical decision making. The central hypothesis of this grant is that non-invasive cardiac magnetic resonance and blood biomarkers can detect myocardial abnormalities consistent with acute rejection in pediatric heart transplant recipients and can predict the need for endomyocardial biopsy. To address this hypothesis, Aim 1 will develop and validate a comprehensive predictive model for identifying PHTx recipients having suspected AR and requiring cardiac catheterization. Aim 2 will evaluate whether blood biomarkers improve the CMR model developed in Aim 1. SubAims will include assessment of cost to determine the most cost-efficient screening protocol. Aim 3 will expand modeling to determine severity of AR as defined histologically. This multi-PI proposal is a prospective, multicenter study to perform CMR in PHTx with and without AR who are also undergoing clinical biopsy. The innovation of this study is the use of advanced CMR, texture analysis, and blood biomarkers for the non-invasive detection of AR. This proposal leverages the support of the Congenital/Pediatric Research Committee within the Society of Cardiovascular Magnetic Resonance (SCMR). Application of these data to clinical practice could improve quality of life and decrease associated morbidity by ensuring that only patients with a high probability of rejection undergo biopsy.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Hospital
        • Contact:
          • Study Coordinator
          • Phone Number: 501-364-4000
          • Email: peac@vumc.org
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital of Los Angeles
        • Contact:
          • Study Coordinator
          • Phone Number: 323-361-2461
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Lucile Packard Children's Hospital at Stanford
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 13123
        • Recruiting
        • Children's Hospital Colorado
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida
        • Contact:
          • Study Coordinator
          • Phone Number: (352) 273-7770
          • Email: peace@vumc.org
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Joe DiMaggio Children's Hospital
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Children's Hospital of Atlanta
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 02115
        • Recruiting
        • Lurie Children's Hospital
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Children's Hospital
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Contact:
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Kravis Children's Hospital
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Recruiting
        • Nationwide Children's Hospital
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT Health Houston
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy pediatric heart transplant recipients
Pediatric heart transplant recipients not having rejection
Pediatric heart transplant recipients with acute rejection
Pediatric heart transplant recipients with acute rejection (ACR or AMR) as defined by the the core pathologist.
Healthy controls
Healthy control patients retrospectively enrolled at each site to standardize parametric mapping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute rejection
Time Frame: time of enrollment
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 of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

August 12, 2026

First Submitted That Met QC Criteria

August 12, 2026

First Posted (Actual)

August 18, 2026

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 220773
  • R01HL164995 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Study conclusion

IPD Sharing Access Criteria

We will honor requests for sharing of requested data for non-profit research purposes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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