Biomarker Panel for Heart Transplant Rejection
(OPTIMAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new ways to manage the immune system in individuals who have recently undergone a heart transplant. Researchers are examining microRNA—small molecules that help control gene expression—to better understand the body's reaction to the new heart. The goal is to develop a test that informs doctors about how well a patient's immune system is adjusting post-transplant. This trial suits adults who had a heart transplant within the last month and plan to continue their follow-up care at the same center for at least a year. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in post-transplant care.
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a new approach to managing post-heart transplant care by focusing on microRNA levels. Unlike traditional immunosuppressive treatments that broadly suppress the immune system to prevent organ rejection, this trial investigates how targeting specific microRNA could offer a more precise method for controlling the body's immune response. This approach has the potential to minimize side effects and improve the long-term health of transplant patients, offering a promising advancement over the current standard of care.
Who Is on the Research Team?
Palak Shah, MD
Principal Investigator
Inova Schar Heart and Vascular
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Post-Transplant Monitoring
Patients follow the center's standard of care surveillance schedule after transplant, with blood samples collected for miR evaluation and other biomarker assessments.
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on infection and rejection events.
What Are the Treatments Tested in This Trial?
Find a Clinic Near You
Who Is Running the Clinical Trial?
Inova Health Care Services
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
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