Recruiting

MicroRNAs

Sponsor:

Northwestern University

Code:

NCT06532890

Conditions

Cardiac Failure

Graft Rejection

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06532890

Start date

Feb 6, 2025

Status verified date

Aug, 2026

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Oct 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 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 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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients [ Time Frame: up to 2 years post-transplant ]
  • Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients [ Time Frame: up to 2 years post-transplant ]

Central Contacts and Locations

Central contacts

Palak Shah, MD

312-694-7805optima@northwestern.edu

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Rebecca Hill

Rebecca.Hill@childrenscolorado.org

Principal Investigator:

Shelley Miyamoto, MD

Ann & Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Stephanie Brazis

(312) 227-0201sbrazis@luriechildrens.org

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Christine Cislo

ccislo@med.umich.edu

Principal Investigator:

David Peng, MD

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Reina Puri

rp3222@cumc.columbia.edu

Principal Investigator:

Marc Richmond, MD

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Kyla Thorn

4126926061thornk2@upmc.edc

Principal Investigator:

Brian Feingold, MD

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Darlene Fountain

darlene.fountain@vumc.org

Principal Investigator:

David Bearl, MD

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Blake Fallon

bxfallo1@texaschildrens.org

Principal Investigator:

Joseph Spinner, MD

More Information

Sponsor

Northwestern University

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-08-25.