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Non-invasive Prediction of EArly Cardiac rEjection (PEACE)

17. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Jonathan Soslow, MD MSCI
Telefonnummer: 615-322-7447
E-post: PEACE@vumc.org

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Barn
Voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Acute rejection Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Vanderbilt University Medical Center

Samarbeidspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. mars 2023

Primær fullføring (Antatt)

1. februar 2027

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

12. august 2026

Først innsendt som oppfylte QC-kriteriene

12. august 2026

Først lagt ut (Faktiske)

18. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. august 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

220773
R01HL164995 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

IPD-delingstidsramme

Study conclusion

Tilgangskriterier for IPD-deling

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .