Personalizing adult heart transplant immunosuppression using blood microRNA levels
Official title: OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels
Run by Northwestern University · NCT06939751 · Data updated 2026-11-12
This project will try to use blood microRNA patterns to monitor immune status in adults after heart transplant and predict who will develop infection or rejection.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Northwestern University Academic / other |
| Locations | 6 sites (Los Angeles, California and 5 other locations) |
| Status | Recruiting |
| Started | October 28, 2025 |
| Main results expected | January 1, 2031 |
| Study ends | January 1, 2032 |
| Registry record updated | August 11, 2026 |
| Trial ID | NCT06939751 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who received a single-organ orthotopic heart transplant within the prior month (±2 weeks) and can return to the transplant center for follow-up are ideal candidates.
✕Probably not a fit
Patients with multi-organ transplants, ongoing mechanical circulatory support or hemodynamic instability, current dialysis, active infection, or active treated rejection are unlikely to be eligible or to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, multicenter, observational cohort will enroll about 250 adults around one month after orthotopic heart transplant and follow them for 36 months. Blood samples will be collected at scheduled post-transplant intervals and whenever clinical events like treated rejection or infection occur to measure circulating microRNA expression. Researchers will compare microRNA patterns with immunosuppressive drug use, HLA/DSA testing, endomyocardial biopsy, dd-cfDNA, echocardiography, and clinical outcomes. The aim is to develop a non-invasive microRNA biomarker panel that reflects net immune state and predicts risk of infection and rejection.
Why it matters
Potential benefit: If successful, this could provide a non-invasive blood test to help tailor immunosuppression, lowering infection risk without increasing rejection.
How similar studies have gone: Related genomic tools like gene-expression profiling and donor-derived cell-free DNA have shown promise for transplant monitoring, but microRNA-based panels remain largely investigational with limited independent validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years at enrollment * Receipt of orthotopic heart transplant (OHT) within the prior 1 month ± 2 weeks * Planned follow-up at the transplant center for a minimum of one-year. * Patient 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 (e.g., inotrope or vasopressor therapy) * Ongoing need for renal replacement therapy and/or dialysis * Active infection requiring either a) hospitalization b) treatment with antimicrobial therapy or c) reduction in immunosuppression * Active rejection being treated with intravenous medications or plasmapheresis
Where it's running
-
Cedars-Sinai Medical Center
Los Angeles, California, United States Recruiting -
Stanford University
Palo Alto, California, United States Recruiting -
Tufts Medical Center
Boston, Massachusetts, United States Recruiting -
Medical University of South Carolina
Charleston, South Carolina, United States Recruiting -
Vanderbilt University
Nashville, Tennessee, United States Recruiting -
Baylor University Medical Center
Dallas, Texas, United States Recruiting
Study contacts
- Study coordinator: Palak Shah, MD
- Email: optimal@northwestern.edu
- Phone: 312-694-7805
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.