The TOGETHER Project - Heart

Mayo Clinic

Status: Completed

Conditions: Heart Transplant Rejection

Study type: Observational

Funder types: Other

Identifiers

NCT03833050

17-000682

Details and patient eligibility

About

The researchers are trying to develop a way to measure the risk of transplant rejection with a blood test.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.

Trial design

101 participants in 1 patient group

Heart Transplant Recipients

Description:

Heart Transplant Recipients meeting the criteria for enrollment and consented will be followed post transplant for 1 year after enrollment into the study. Blood samples will be obtained at their 1, 3, 6, 12 months and any for cause heart biopsy's obtained. There will be no active intervention for recipients that are enrolled. Results from the samples will not be obtained in real time.