What is the Purpose of this Study?
The purpose of this study is to identify blood biomarkers that could be used to predict infection and rejection after heart transplant. A biomarker is a biological molecule found in blood or other body fluids that may be a sign of a disease and can be used to predict response to a specific treatment. The study aims to develop an experimental blood test that can help balance immunosuppression medications after transplant. Eligible adult patients will be enrolled into the study approximately 1 month after heart transplantation. Blood samples will be collected to understand how certain blood-based markers respond to changes in immunosuppression medications. Researchers will also collect participants’ transplantation and laboratory data, echocardiography images and reports, medication records, and other clinical data. The standard care after transplant will not be altered by participation in this study.
Eligibility
- * 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.
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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
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
OPtimal Adult Heart Transplant Immunosuppression with MicroRNA Levels Study