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OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels

RecruitingObservational study

Who can join

Ages 18 to 99 · All sexes

Full eligibility 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

About the study

This study aims to develop and refine a microRNA (miR) biomarker panel that can be used to phenotype net immune state after heart transplantation using circulating miRs (associated with drug doses and levels). These miRs will be used to characterize the overall immune state in adult heart transplant patients and predict patients that will go on to develop infection and rejection. MicroRNAs (miRs) are small, non-coding RNA molecules that regulate gene expression and serve as molecular biomarkers found in the circulation.

Sponsor: Northwestern University · Participants: 250 · Started: Oct 28, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06939751

Locations in the U.S.

CaliforniaCedars-Sinai Medical Center, Los Angeles
Stanford University, Palo Alto
MassachusettsTufts Medical Center, Boston
South CarolinaMedical University of South Carolina, Charleston
TennesseeVanderbilt University, Nashville
TexasBaylor University Medical Center, Dallas

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.