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Non-invasive Prediction of EArly Cardiac rEjection (PEACE)

17 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

200

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Jonathan Soslow, MD MSCI
Telefoonnummer: 615-322-7447
E-mail: PEACE@vumc.org

Studie Locaties

Verenigde Staten
- Arkansas
  - Little Rock, Arkansas, Verenigde Staten, 72202
    - Werving
    - Arkansas Children's Hospital
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 501-364-4000
      
      E-mail: peac@vumc.org
- California
  - Los Angeles, California, Verenigde Staten, 90027
    - Werving
    - Children's Hospital of Los Angeles
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 323-361-2461
  - Los Angeles, California, Verenigde Staten, 90095
    - Werving
    - UCLA
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 310-267-7667
      
      E-mail: peace@vumc.org
  - Palo Alto, California, Verenigde Staten, 94304
    - Werving
    - Lucile Packard Children's Hospital at Stanford
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 650-337-3766
      
      E-mail: peace@vumc.org
  - San Diego, California, Verenigde Staten, 92123
    - Werving
    - Rady Children's Hospital
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 858-966-5855
      
      E-mail: peace@vumc.org
- Colorado
  - Denver, Colorado, Verenigde Staten, 13123
    - Werving
    - Children's Hospital Colorado
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 720-777-6820
      
      E-mail: peace@vumc.org
- Florida
  - Gainesville, Florida, Verenigde Staten, 32608
    - Werving
    - University of Florida
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: (352) 273-7770
      
      E-mail: peace@vumc.org
  - Hollywood, Florida, Verenigde Staten, 33021
    - Werving
    - Joe DiMaggio Children's Hospital
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 954-265-3437
      
      E-mail: peace@vumc.org
- Georgia
  - Atlanta, Georgia, Verenigde Staten, 30322
    - Werving
    - Children's Hospital of Atlanta
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 404-256-2593
      
      E-mail: peace@vumc.org
- Illinois
  - Chicago, Illinois, Verenigde Staten, 02115
    - Werving
    - Lurie Children's Hospital
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 312-227-4000
      
      E-mail: peace@vumc.org
- Indiana
  - Indianapolis, Indiana, Verenigde Staten, 46202
    - Werving
    - Riley Children's Hospital
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 317-944-8906
      
      E-mail: peace@vumc.org
- Massachusetts
  - Boston, Massachusetts, Verenigde Staten, 02115
    - Werving
    - Boston Children's Hospital
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 617-355-6000
      
      E-mail: peace@vumc.org
- Michigan
  - Ann Arbor, Michigan, Verenigde Staten, 48109
    - Werving
    - University of Michigan
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 734-764-5176
      
      E-mail: peace@vumc.org
- Missouri
  - St Louis, Missouri, Verenigde Staten, 63110
    - Werving
    - Washington University
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 314-454-6095
      
      E-mail: peace@vumc.org
- New York
  - New York, New York, Verenigde Staten, 10032
    - Werving
    - Columbia University
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 212-305-4432
      
      E-mail: peace@vumc.org
  - New York, New York, Verenigde Staten, 10029
    - Werving
    - Mount Sinai Kravis Children's Hospital
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 212-241-9500
      
      E-mail: peace@vumc.org
- Ohio
  - Columbus, Ohio, Verenigde Staten, 43205
    - Werving
    - Nationwide Children's Hospital
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 614-722-2530
      
      E-mail: peace@vumc.org
- Tennessee
  - Nashville, Tennessee, Verenigde Staten, 37232
    - Werving
    - Vanderbilt University Medical Center
    - Contact:
      
      Study Coordinator
      
      E-mail: peace@vumc.org
- Texas
  - Houston, Texas, Verenigde Staten, 77030
    - Werving
    - Texas Children's Hospital
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 832-824-3278
      
      E-mail: peace@vumc.org
  - Houston, Texas, Verenigde Staten, 77030
    - Werving
    - UT Health Houston
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 713-486-6755
      
      E-mail: peace@vumc.org
- Washington
  - Seattle, Washington, Verenigde Staten, 98105
    - Werving
    - Seattle Children's Hospital
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 206-987-2000
      
      E-mail: peace@vumc.org
- Wisconsin
  - Milwaukee, Wisconsin, Verenigde Staten, 53226
    - Werving
    - Medical College of Wisconsin
    - Contact:
      
      Study Coordinator
      
      Telefoonnummer: 414-266-6457
      
      E-mail: peace@vumc.org

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Kind
Volwassen

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Acute rejection Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Vanderbilt University Medical Center

Medewerkers

National Heart, Lung, and Blood Institute (NHLBI)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

29 maart 2023

Primaire voltooiing (Geschat)

1 februari 2027

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

12 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 augustus 2026

Eerst geplaatst (Werkelijk)

18 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

17 augustus 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

220773
R01HL164995 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

IPD-tijdsbestek voor delen

Study conclusion

IPD-toegangscriteria voor delen

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .