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/Actively Recruiting
Led by Northwestern University · Updated on 2026-08-11
250
Participants Needed
6
Research Sites
52 weeks
Total Duration
Researchers are studying adult heart transplant patients to develop a microRNA miR biomarker panel that can help identify the immune state after transplantation. This study focuses on using circulating miRs, which are small molecules in the blood linked to drug levels, to predict which patients might develop infections or rejection after their transplant. The goal is to better understand immune function and improve monitoring in these patients. This is a prospective, multicenter observational study involving about 250 heart transplant patients in the United States. Participants are enrolled approximately one month after their transplant and follow their centers standard care schedule. Blood samples will be collected at specific times and during clinical events such as infection or rejection. Researchers will analyze these samples for miR expression and other related biomarkers, along with additional data like medical history, medications, antibody evaluations, biopsies, echocardiography, and donor-derived cell-free DNA. Participants will be followed for 36 months, during which their health and lab results will be closely monitored. The study will measure how miRs predict infections and rejection events over time. The research aims to create a non-invasive blood test to better guide immunosuppression management, balancing the risks of infection and rejection. This long-term follow-up will help improve care and outcomes for heart transplant patients.
CONDITIONS
OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels
P
Palak Shah, MD
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Northwestern University
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 36 months
Participants follow their standard care schedule while blood samples and health data are collected at specific times and during clinical events like infection or rejection.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Palak Shah, Michael R Bristow, J David Port
https://pubmed.ncbi.nlm.nih.gov/28940102/Palak Shah, Sean Agbor-Enoh, Pramita Bagchi...
https://pubmed.ncbi.nlm.nih.gov/35872109/Northwestern University
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor