Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs (OPTIMA)

Last updated: April 30, 2025
Sponsor: Inova Health Care Services
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Chest Pain

Transplant Rejection

Treatment

N/A

Clinical Study ID

NCT06532890
INOVA-2024-197
Enduring Hearts Awards#1248960
AHA Award Number:1248960
  • Ages < 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age ≤ 18 years at enrollment

  • Receipt of orthotopic heart transplant (OHT) within the prior 1 month ± 2 weeks

  • Planned follow-up at the transplant center for a minimum of one-year.

  • Caregiver able and willing to comply with the study visit schedule, studyprocedures, and study requirements.

Exclusion

Exclusion Criteria:

  • Recipient of a multi-organ transplant

  • History of prior solid organ transplant before the index heart transplant

  • Ongoing mechanical circulatory support or hemodynamic instability

  • Active infection requiring either a) hospitalization b) treatment with antimicrobialtherapy or c) reduction in immunosuppression

  • History of rejection prior to enrollment

  • Inability to collect specified blood volume at enrollment +/- 1 week

Study Design

Total Participants: 150
Study Start date:
February 06, 2025
Estimated Completion Date:
October 01, 2029

Study Description

The study objectives will be accomplished in a prospective, multicenter observational, longitudinal cohort study that includes 100-150 Pediatric Heart Transplant (PHT) patients from the United States. Patients will be screened for eligibility and enrolled ~1 month after PHT. Study participation will last 24 months.

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 rejection, infection, or major change in immunosuppression.

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.

Connect with a study center

  • Columbia University

    New York, New York 10032
    United States

    Active - Recruiting

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Inova Health System

    Falls Church, Virginia 22042
    United States

    Site Not Available

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