Actively Recruiting

Age: 0 - 18Years
All Genders
NCT06532890

Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs

Led by Inova Health Care Services · Updated on 2026-03-25

150

Participants Needed

7

Research Sites

242 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 64 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
Not Eligible

You will not qualify if you...

  • 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 (not including prophylaxis 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

2

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

3

Columbia University

New York, New York, United States, 10032

Actively Recruiting

4

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

5

Vanderbilt University

Nashville, Tennessee, United States, 37232

Actively Recruiting

6

Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

7

Inova Health System

Falls Church, Virginia, United States, 22042

Not Yet Recruiting

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Research Team

P

Palak Shah, MD

CONTACT

S

Stephanie Wolak, MPH

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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