Actively Recruiting

Age: 18Years - 99Years
All Genders
NCT06939751

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

322 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

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

Official Title

OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3E�3D 18 years at enrollment
  • Received orthotopic heart transplant (OHT) within the prior 1 month �B1 2 weeks
  • Planned follow-up at the transplant center for a minimum of one year
  • Able and willing to comply with the study visit schedule, procedures, and requirements
Not Eligible

You will not qualify if you...

  • 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 hospitalization, antimicrobial therapy, or reduction in 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

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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

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Research Team

P

Palak Shah, MD

CONTACT

S

Stephanie Wolak, MPH

CONTACT

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

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OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels | DecenTrialz