Identifying microRNAs to improve heart transplant outcomes in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify circulating microRNAs that can help characterize the immune state in pediatric heart transplant patients and predict the likelihood of developing infections and graft rejection. It will involve a prospective, multicenter cohort of 100-150 patients from various transplant centers across the United States, with blood samples collected at specified intervals and during clinical events. The goal is to develop a non-invasive genomic blood test to monitor patients post-transplant, thereby reducing complications associated with immunosuppression.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Ann & Robert H. Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Columbia University
  New York, New York, United States Recruiting
• University of Pittsburgh
  Pittsburgh, Pennsylvania, United States Recruiting
• Vanderbilt University
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Palak Shah, MD
• Email: optima@northwestern.edu
• Phone: 312-694-7805

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.