OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels (Optimal)

Launched by INOVA HEALTH CARE SERVICES · Apr 15, 2025

Keywords

ClinConnect Summary

The OPtimal trial is a study designed to improve the way doctors monitor and manage patients who have received a heart transplant. The researchers are focusing on a specific group of molecules called microRNAs that could help them understand the body's immune response after the transplant. This understanding may lead to better prevention of heart issues or organ rejection, which is when the body’s immune system attacks the new heart.

To be eligible for this trial, participants need to be at least 18 years old and have had a heart transplant within the last month. They should also be able to attend follow-up visits at the transplant center for at least one year. However, people who have received multiple organ transplants or have certain medical conditions, like ongoing infections or heart failure that requires special treatments, will not be able to take part. If you join the study, you can expect to have regular check-ups and tests to help gather important information about your recovery and immune response.

Gender

ALL

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