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/28940102Actively Recruiting
Age: 18Years - 99Years
All Genders
ID06939751
OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels
Led by Inova Health Care Services · Updated on 2026-04-22
250
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Inova Health Care Services
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adult heart transplant patients to develop and improve a panel of microRNA (miR) biomarkers that can help describe the immune state after transplantation. These small molecules in the blood are linked with drug doses and levels and may predict which patients will develop infections or rejection. The study is an observational, prospective, multicenter, and longitudinal cohort involving about 250 patients in the United States. Participants will be enrolled about one month after their heart transplant and followed for 36 months. Blood samples will be collected at specific times after transplant and during clinical events such as rejection or infection. The study will also collect data on demographics, medical history, medications, antibody evaluations, biopsies, echocardiography, donor-derived cell-free DNA, and other transplant-related tests. Throughout the study, patients will follow their center's usual care schedule. Researchers will analyze blood samples for miR expression and other biomarkers to better understand immune function and immunosuppression effects. The main outcomes measured are the time until infection or rejection events, observed for up to three years post-transplant. This research aims to create a non-invasive genomic blood test to help monitor and reduce complications after heart transplant.
CONDITIONS
Brief Title
OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels
Who Can Participate
Age: 18Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age �318 years at enrollment
- Received orthotopic heart transplant within the prior 1 month �318 2 weeks
- Planned follow-up at the transplant center for at least one year
- Able and willing to comply with study visits, procedures, and requirements
You will not qualify if you...
- Recipient of a multi-organ transplant
- History of prior solid organ transplant before the current heart transplant
- Ongoing mechanical circulatory support or hemodynamic instability
- Need for renal replacement therapy or dialysis
- Active infection requiring hospitalization, antimicrobial treatment, or reduced immunosuppression
- Active rejection being treated with intravenous medications or plasmapheresis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surveillance
Duration - 36 months
Participants who have undergone heart transplant and enrollment are observed through the center's standard of care surveillance schedule. Blood samples are collected at specified intervals and during clinical events such as treated rejection or infection. Additional data including demographics, medical history, medications, and other post-transplant testing are collected.
Visits according to standard post-transplant care schedule
Trial Site Locations
Total: 7 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
3
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
5
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
6
Baylor University Medical Center
Dallas, Texas, United States, 75246
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
Circulating microRNAs in cellular and antibody-mediated heart transplant rejection.
Palak Shah, Sean Agbor-Enoh, Pramita Bagchi...
https://pubmed.ncbi.nlm.nih.gov/35872109