Heart TransplantPEACENCT07770659
Non-invasive Prediction of EArly Cardiac rEjection
An observational study of Heart Transplant and Pediatric Heart Transplant, run by Vanderbilt University Medical Center at 22 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Heart Transplant, Pediatric Heart Transplant, Rejection
- How many people
- 200 participants
- Where
- 22 sitesUnited States
- Study dates
- 29 Mar 2023to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric heart transplant recipients undergoing endomyocardial biopsy either for concerns of rejection or for routine surveillance.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 22 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Study Coordinator, 734-764-5176, peace@vumc.org
- Recruiting
Children's Hospital of Atlanta
Atlanta, Georgia, 30322
Study Coordinator, 404-256-2593, peace@vumc.org
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Study Coordinator, 617-355-6000, peace@vumc.org
- Recruiting
Lurie Children's Hospital
Chicago, Illinois, 02115
Study Coordinator, 312-227-4000, peace@vumc.org
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Study Coordinator, 614-722-2530, peace@vumc.org
- Recruiting
Children's Hospital Colorado
Denver, Colorado, 13123
Study Coordinator, 720-777-6820, peace@vumc.org
- Recruiting
University of Florida
Gainesville, Florida, 32608
Study Coordinator, (352) 273-7770, peace@vumc.org
- Recruiting
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Study Coordinator, 954-265-3437, peace@vumc.org
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Study Coordinator, 832-824-3278, peace@vumc.org
- Recruiting
UT Health Houston
Houston, Texas, 77030
Study Coordinator, 713-486-6755, peace@vumc.org
- Recruiting
Riley Children's Hospital
Indianapolis, Indiana, 46202
Study Coordinator, 317-944-8906, peace@vumc.org
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Study Coordinator, 501-364-4000, peac@vumc.org
- Recruiting
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Study Coordinator, 323-361-2461
- Recruiting
UCLA
Los Angeles, California, 90095
Study Coordinator, 310-267-7667, peace@vumc.org
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Study Coordinator, 414-266-6457, peace@vumc.org
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Study Coordinator, peace@vumc.org
- Recruiting
Mount Sinai Kravis Children's Hospital
New York, New York, 10029
Study Coordinator, 212-241-9500, peace@vumc.org
- Recruiting
Columbia University
New York, New York, 10032
Study Coordinator, 212-305-4432, peace@vumc.org
- Recruiting
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
Study Coordinator, 650-337-3766, peace@vumc.org
- Recruiting
Rady Children's Hospital
San Diego, California, 92123
Study Coordinator, 858-966-5855, peace@vumc.org
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Study Coordinator, 206-987-2000, peace@vumc.org
- Recruiting
Washington University
St Louis, Missouri, 63110
Study Coordinator, 314-454-6095, peace@vumc.org
About this study
Official title: 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.
Read the 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.
- Keywords
- Pediatric heart transplant, acute rejection, acute cellular rejection, antibody mediated rejection, cardiac mri, cell free DNA
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start29 Mar 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart TransplantStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jonathan Soslow, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770659
- Sponsor's protocol ID
- 220773
- Other IDs
- R01HL164995
- Acronym
- PEACE
- Status last verified
- Jun 2026
- First submitted
- 12 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Heimerl AT, Crum K, Lockard CA, Yan K, Stendahl G, George-Durrett K, Kindel S, Bearl D, North P, Mitchell A, Nicotera J, Auerbach S, Fonseca B, Renno M, Knecht K, Johnson T, Parent JJ, Brown N, Albers E, Detterich J, Menteer J, Beroukhim R, Daly K, Husain N, Magnetta D, Lee MV, Settersten V, DiLorenzo M, Zuckerman W, Lu JC, Lim HM, Butto A, Slesnick T, Printz BJ, Vaughn G, Watanabe K, Hernandez L, Maskatia S, Damon BM, Soslow JH, Samyn MM; PEACE Investigators. Multi-center study of CMR versus cardiac catheterization with endomyocardial biopsy for pediatric transplant surveillance: study protocol. J Cardiovasc Magn Reson. 2026 Oct 18:102819. doi: 10.1016/j.jocmr.2026.102819. Online ahead of print.
PubMed 42893745
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Modeling of Acute Rejection in Pediatric Heart Transplant Recipients
- ClinicalTrials.gov ID
- NCT07770659
- Acronym / sponsor ID
- PEACE / 220773
- Keywords
- Pediatric heart transplant, acute rejection, acute cellular rejection, antibody mediated rejection, cardiac mri, cell free DNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric heart transplant recipients undergoing endomyocardial biopsy either for concerns of rejection or for routine surveillance.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 42893745Heimerl AT, Crum K, Lockard CA, Yan K, Stendahl G, George-Durrett K, Kindel S, Bearl D, North P, Mitchell A, Nicotera J, Auerbach S, Fonseca B, Renno M, Knecht K, Johnson T, Parent JJ, Brown N, Albers E, Detterich J, Menteer J, Beroukhim R, Daly K, Husain N, Magnetta D, Lee MV, Settersten V, DiLorenzo M, Zuckerman W, Lu JC, Lim HM, Butto A, Slesnick T, Printz BJ, Vaughn G, Watanabe K, Hernandez L, Maskatia S, Damon BM, Soslow JH, Samyn MM; PEACE Investigators. Multi-center study of CMR versus cardiac catheterization with endomyocardial biopsy for pediatric transplant surveillance: study protocol. J Cardiovasc Magn Reson. 2026 Oct 18:102819. doi: 10.1016/j.jocmr.2026.102819. Online ahead of print.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant and Pediatric Heart Transplant, run by Vanderbilt University Medical Center at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Soslow, MD MSCI (615-322-7447, PEACE@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute rejection (time frame: time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07770659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.