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Non-invasive Prediction of EArly Cardiac rEjection (PEACE)

17 augusti 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

200

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Barn
Vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / 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.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Acute rejection Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Vanderbilt University Medical Center

Samarbetspartners

National Heart, Lung, and Blood Institute (NHLBI)

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

29 mars 2023

Primärt slutförande (Beräknad)

1 februari 2027

Avslutad studie (Beräknad)

30 juni 2027

Studieregistreringsdatum

Först inskickad

12 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

12 augusti 2026

Första postat (Faktisk)

18 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 augusti 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Tidsram för IPD-delning

Study conclusion

Kriterier för IPD Sharing Access

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .