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The TOGETHER Project - Heart

The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Heart Transplant Recipients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03833050
Acronym
TOGETHER
Enrollment
101
Registered
2019-02-06
Start date
2017-12-07
Completion date
2020-09-22
Last updated
2022-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplant Rejection

Keywords

heart transplant

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.

Interventions

None listed

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
RNA-seq based peripheral blood assay in heart transplant recipients3 yearsCases 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026