The TOGETHER Project - Heart
- Conditions
- Heart Transplant Rejection
- Registration Number
- NCT03833050
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The researchers are trying to develop a way to measure the risk of transplant rejection with a blood test.
- Detailed Description
The study will utilize peripheral blood assays collected at time points that are considered standard of care at most institutions. Subjects will have peripheral blood collected at 1 month, 3 months, 6 months, and 12 months after heart transplantation, as well as any for cause time points. These samples will then be used for purposes of developing an RNA-seq based peripheral blood assay in adult heart transplant recipients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
Patients who meet all of the following criteria are eligible for enrollment as study participants:
- Adult (≥18 years) solitary heart transplant recipient
- Patient is willing and able to provide informed written consent
Patients who meet any of these criteria are not eligible for enrollment as study participants:
- Adult (<18 years) heart transplant recipient
- Patient refusal to enroll in the studyc3. Any simultaneous heart and extra organ transplant, including pancreas, liver, lung, kidney, etc. Subjects who have had previous transplants may be included.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RNA-seq based peripheral blood assay in heart transplant recipients 3 years Cases will be reviewed and a subset of the peripheral blood specimens will be sent to Mayo Clinic Laboratories for development of the RNA-seq signature. The number of specimens analyzed will be determined based on the incidence of rejection and the incidence of biopsies for cause needed to develop the signature.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States