Recruiting

MicroRNA Biomarkers

Sponsor:

Northwestern University

Code:

NCT06939751

Conditions

Cardiac Failure

Graft Rejection

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Cardiac Failure

Graft Rejection

Study ID

NCT06939751

Start date

Oct 28, 2025

Status verified date

Aug, 2026

Completion date

Jan 1, 2032

Anticipated

Primary completion date

Jan 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients [ Time Frame: up to 3 years post - transplant ]
  • Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients [ Time Frame: up to 3 years post - transplant ]

Central Contacts and Locations

Central contacts

Palak Shah, MD

312-694-7805optimal@northwestern.edu

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Lucilla Garcia

lucilla.garcia@csmns.org

Principal Investigator:

Jon Kobashigawa, MD

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

James Pak

jamespak@stanford.edu

Principal Investigator:

Kiran Khush, MD

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Abena Adwetewa-Badu

617-636-9458Abena.Adwetewa-Badu@tuftsmedicine.org

Principal Investigator:

Jeong Hwan Kim, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Melissa Amitrano

amitrano@musc.edu

Principal Investigator:

Ryan Tedford, MD

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Lisa Slinger

Lisa.slinger@vumc.org

Principal Investigator:

Kelly Schlendorf, MD

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Jasha Harvey

jasha.harvey@BSWHealth.org

Principal Investigator:

Shelley Hall, MD

More Information

Sponsor

Northwestern University

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-08-11.