Identifying microRNAs to improve heart transplant outcomes in children
Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs
This study is trying to find specific microRNAs in the blood of children who have had heart transplants to see if they can help predict infections and rejection of the new heart.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Inova Health Care Services Academic / other |
| Locations | 7 sites (Aurora, Colorado and 6 other locations) |
| Trial ID | NCT06532890 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 18 years or younger who have received a heart transplant within the last month.
Not a fit: Patients who have received multi-organ transplants or have ongoing infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of pediatric heart transplant patients, reducing the risk of infections and rejection.
How similar studies have performed: Other studies have shown promise in using microRNAs as biomarkers in various conditions, suggesting potential success for this novel approach in pediatric heart transplantation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aurora, Colorado and 6 other locations
- Children's Hospital Colorado — Aurora, Colorado, 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)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- Inova Health System — Falls Church, Virginia, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Palak Shah, MD — Inova Schar Heart and Vascular
- Study coordinator: Palak Shah, MD
- Email: palak.shah@inova.org
- Phone: (703) 776-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.