RecruitingNCT06532890

Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs


Sponsor

Inova Health Care Services

Enrollment

150 participants

Start Date

Feb 6, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This study aims to discover circulating microRNAs (associated with drug doses and levels) that can be used to characterize the overall immune state in pediatric heart transplant patients and predict patients that will go on to develop infection and rejection. MicroRNAs (miRs) are small, non-coding RNA molecules that regulate gene expression and serve as molecular biomarkers found in the circulation.


Eligibility

Max Age: 18 Years

Inclusion Criteria4

  • Age ≤ 18 years at time of transplant listing
  • 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 Criteria6

  • Recipient of a multi-organ transplant
  • 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

Locations(7)

Children's Hospital Colorado

Aurora, Colorado, United States

University of Michigan

Ann Arbor, Michigan, United States

Columbia University

New York, New York, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

Texas Children's Hospital

Houston, Texas, United States

Inova Health System

Falls Church, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06532890


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