OPTIMAL

OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels (OPTIMAL)

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Heart transplantation
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All genders
person-wave 18+
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Recruiting now
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Overview
Principal Investigator: Jeong Hwan Kim

This is a prospective, multicenter observational, longitudinal cohort study. Patients will be enrolled into the study approximately 1 month (± 2 weeks) after heart transplantation. All patients will follow the center's standard of care surveillance schedule after transplant. Research blood samples will be collected for miR evaluation at 1) specified time intervals after transplant and 2) when a clinical event of interest occurs, including rejection or infection.

Research samples will be collected and used to evaluate microRNA expression as well as other biomarkers related to heart transplantation and immunosuppression medications.

Additional data collection will include demographics, medical history, medications, human leukocyte (HLA)/donor specific antibody (DSA) evaluations, endomyocardial biopsy (EMB), echocardiography, donor-derived cell-free DNA (dd-cfDNA), and other post-transplant events and testing. 

Contact Us

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Abena Adwetewa-Badu and Gaurav Das (Gaurav.Das@tuftsmedicine.org)

Study details
Inclusion Criteria
  • Age ≥ 18 years at time of 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
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)
Study Requirements

- At Enrollment (about 1 month after transplant): you will be asked to sign this consent form, we will collect health information about your heart transplant, medical history, laboratory data, antibody and cell-free DNA test results, echocardiography and cardiac catheterization reports. You will also have a blood sample collected for research. 
- At 3, 6, 12, 18, 24, 30 and 36 months after transplant: we will collect health information about changes in your medical history, laboratory data, antibody and cell-free DNA test results, echocardiography and cardiac catheterization reports. You will also have a blood sample collected for research except for the 30-month telephone/virtual visit. 
- If you experience infection or rejection after transplant: we will collect information about those medical events. You will also have a blood sample collected for research. 
-If you have a change in your immunosuppression medications after transplant (by your treating physicians). We will collect information about those medication changes.
-Whenever possible, blood samples for this research study will be drawn when you are already having a blood draw for a clinical test. The amount of blood we will take for each visit will be up to 30 mL which is about 5-6 teaspoons.