Circulating microRNAs in cellular and antibody-mediated heart transplant rejection.
Palak Shah, Sean Agbor-Enoh, Pramita Bagchi...
https://pubmed.ncbi.nlm.nih.gov/35872109Actively Recruiting
Age: 0 - 18Years
All Genders
ID06532890
Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs
Led by Inova Health Care Services · Updated on 2026-03-25
150
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to identify circulating microRNAs that relate to drug doses and immune status in children who have had heart transplants. The study focuses on predicting which patients may develop infections or rejection after transplant by examining these small molecules that regulate gene expression. This observational study involves pediatric heart transplant patients to improve monitoring of their immune health. The study includes 100 to 150 pediatric heart transplant patients from the United States, enrolled between 10 and 50 days after their transplant. Participants will follow their center's usual care schedule for monitoring after transplant. Blood samples will be collected at set times and during clinical events such as infection or treated rejection to evaluate microRNA levels and other biomarkers. The data collected will also include medical history, medication use, antibody evaluations, biopsies, echocardiograms, and donor-derived DNA. Participants will be observed for 24 months while researchers track microRNA patterns and their ability to predict infection and rejection up to two years post-transplant. The study will use blood tests and other clinical data to assess immune status and transplant complications without altering standard care. This work aims to develop a non-invasive blood test to guide immunosuppression treatment and reduce risks related to over- or under-immunosuppression.
CONDITIONS
Brief Title
Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs
Who Can Participate
Age: 0 - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or younger at the time of transplant listing
- Within 10 to 50 days after orthotopic heart transplant at enrollment
- Planned follow-up at the transplant center for at least one year
- Caregiver able and willing to follow study visit schedule and procedures
You will not qualify if you...
- Recipient of a multi-organ transplant
- History of prior solid organ transplant before this heart transplant
- Ongoing mechanical circulatory support or unstable condition after transplant
- Active infection requiring hospitalization or antimicrobial treatment (excluding prophylaxis or suppressive antibiotics)
- History of treated rejection before study enrollment
- Unable to provide required blood samples before 50 days post-transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 10 to 50 days after heart transplant
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Surveillance
Duration - Up to 24 months
Participants who undergo routine post-transplant care are observed. Blood samples and other data are collected at specified time intervals and during clinical events such as treated rejection or infection to evaluate microRNA expression and other biomarkers.
Follow-up visits according to the transplant center's standard of care surveillance schedule
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
Loading map...
Research Team
P
Palak Shah, MD
S
Stephanie Wolak, MPH
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
MicroRNAs in Heart Failure, Cardiac Transplantation, and Myocardial Recovery: Biomarkers with Therapeutic Potential.
Palak Shah, Michael R Bristow, J David Port
https://pubmed.ncbi.nlm.nih.gov/28940102