Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs

NCT06532890 | Recruiting

• 2 other identifiers: INOVA-2024-197Enduring Hearts Awards#1248960
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Cardiac Failure; Graft Rejection

Outcome Measures

Primary Outcomes (2)

• Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients

  A time-to-event analysis will be performed to identify specific circulating microRNAs (miRs) that predict the risk of infection in heart transplant recipients. Infections are defined as any bacterial, viral, fungal, or opportunistic infection leading to: 1) hospitalization, 2) prescription of antimicrobial therapy, or 3) reduction in immunosuppression.

  up to 2 years post-transplant

• Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients

  A time-to-event analysis will be performed to identify specific circulating microRNAs (miRs) that predict the risk of rejection in heart transplant recipients. Rejection is defined as treated rejection based on 1) endomyocardial biopsy (EMB) pathology, 2) unexplained graft dysfunction, or 3) molecular testing; leading to treatment with pulse dose steroids, monoclonal antibodies, plasmapheresis, and/or intravenous immunoglobulin (IVIg).

  up to 2 years post-transplant

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients ≤ 18 years of age at time of transplant listing from geographically and socioeconomically diverse regions of the U.S. who have undergone orthotopic heart transplant (OHT). Patients will be screened for eligibility and enrolled 10-50 days after pediatric heart transplantation.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (7)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37232, United States

RECRUITING

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

Inova Health System

Falls Church, Virginia, 22042, United States

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 35872109 BACKGROUND

• 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.

  PMID: 28940102 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and RNA

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Palak Shah, MD

  Inova Schar Heart and Vascular

  PRINCIPAL INVESTIGATOR

• Jason Goldberg, MD

  Inova L.J. Murphy Children's Hospital

  STUDY DIRECTOR

Central Study Contacts

Palak Shah, MD

CONTACT

(703) 776-8000; palak.shah@inova.org

Stephanie Wolak, MPH

CONTACT

571-472-8558; stephanie.wolak@inova.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: February 6, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: March 25, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)