Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs
NCT ID: NCT06532890
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2025-02-06
2029-10-01
Brief Summary
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Detailed Description
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All patients will follow the center's standard of care surveillance schedule after transplant. Blood samples will be collected for miR evaluation at:
1. specified time intervals after transplant and
2. when a clinical event of interest occurs, including treated rejection, or infection.
Research samples will be collected and used to evaluate microRNA expression as well as other biomarkers related to heart transplantation and immunosuppression medications. Additional data collection will include demographics, medical history, medications, human leukocyte (HLA)/donor specific antibody (DSA) evaluations, endomyocardial biopsy (EMB), echocardiography, donor-derived cell-free DNA (dd-cfDNA), and other post-transplant events and testing.
This work will form the basis for a non-invasive, genomic blood test that can be used to monitor patients after heart transplant to mitigate complications of over-immunosuppression, such as infection, without increasing the risks of under-immunosuppression, such as rejection.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Subject is within 10-50 days post-orthotopic heart transplant at time of enrollment.
* Planned follow-up at the transplant center for a minimum of one-year.
* Caregiver able and willing to comply with the study visit schedule, study procedures, and study requirements.
Exclusion Criteria
* History of prior solid organ transplant before the index heart transplant
* Ongoing mechanical circulatory support or hemodynamic instability after transplant
* Active infection requiring either a) hospitalization or b) treatment with antimicrobial drugs (does not include prophylaxis for infection or suppressive antibiotics given after transplant)
* History of treated rejection prior to study enrollment
* Inability to collect specified blood volume after enrollment and prior to 50 days post-transplant
18 Years
ALL
No
Sponsors
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Inova Health Care Services
OTHER
Responsible Party
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Principal Investigators
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Palak Shah, MD
Role: PRINCIPAL_INVESTIGATOR
Inova Schar Heart and Vascular
Jason Goldberg, MD
Role: STUDY_DIRECTOR
Inova L.J. Murphy Children's Hospital
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Columbia University
New York, New York, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
Inova Health System
Falls Church, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Lily Sajbel
Role: primary
Reina Puri
Role: primary
Kyla Thorn
Role: primary
Wendi Welch
Role: primary
Blake Fallon
Role: primary
References
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Shah P, Agbor-Enoh S, Bagchi P, deFilippi CR, Mercado A, Diao G, Morales DJ, Shah KB, Najjar SS, Feller E, Hsu S, Rodrigo ME, Lewsey SC, Jang MK, Marboe C, Berry GJ, Khush KK, Valantine HA; GRAfT Investigators. Circulating microRNAs in cellular and antibody-mediated heart transplant rejection. J Heart Lung Transplant. 2022 Oct;41(10):1401-1413. doi: 10.1016/j.healun.2022.06.019. Epub 2022 Jun 28.
Shah P, Bristow MR, Port JD. MicroRNAs in Heart Failure, Cardiac Transplantation, and Myocardial Recovery: Biomarkers with Therapeutic Potential. Curr Heart Fail Rep. 2017 Dec;14(6):454-464. doi: 10.1007/s11897-017-0362-8.
Other Identifiers
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Enduring Hearts Awards#1248960
Identifier Type: OTHER
Identifier Source: secondary_id
INOVA-2024-197
Identifier Type: -
Identifier Source: org_study_id