The TOGETHER Project - Heart

Mayo Clinic101 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

101

Conditions

Heart Transplant Rejection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Mayo Clinic

Phoenix, Arizona, United States

Mayo Clinic

Jacksonville, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

RNA-seq based peripheral blood assay in heart transplant recipients

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.

Time frame: 3 years

Data from ClinicalTrials.gov

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