Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs (OPTIMA)

Launched by INOVA HEALTH CARE SERVICES · Jul 29, 2024

Keywords

ClinConnect Summary

The OPTIMA trial is a research study focused on improving care for children who have received a heart transplant. The goal of this study is to find specific tiny molecules called microRNAs in the blood that can help doctors understand how well a child's immune system is functioning after the transplant. This information could help predict if a child might face complications, such as infections or rejection of the new heart.

To participate in this trial, children must be 18 years old or younger and have had a heart transplant within the last month. They also need to be able to visit the transplant center for regular check-ups for at least a year. If a child is dealing with other serious health issues or has had a different organ transplant before, they may not be eligible. Families who join the study can expect to have blood samples taken at specific times to help researchers gather the necessary information. Overall, this trial aims to improve the care and outcomes for young heart transplant patients.

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.
• • Caregiver 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
• • Active infection requiring either a) hospitalization b) treatment with antimicrobial therapy or c) reduction in immunosuppression
• • History of rejection prior to enrollment
• • Inability to collect specified blood volume at enrollment +/- 1 week