250 Participants Needed

Biomarker Panel for Heart Transplant Rejection

(OPTIMAL Trial)

Recruiting at 1 trial location
PS
MR
Overseen ByMichaela Ramandanes, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

PS

Palak Shah, MD

Principal Investigator

Inova Schar Heart and Vascular

Are You a Good Fit for This Trial?

Inclusion Criteria

I received a heart transplant within the last 6 weeks.
I am willing and able to follow the study's schedule and procedures.
I will follow up at the transplant center for at least one year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on infection and rejection events.

up to 3 years

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

Trials
80
Recruited
22,700+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+