The TOGETHER Project

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-07

Study Completion Date

2020-09-22

Brief Summary

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

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Detailed Description

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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.

Conditions

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Heart Transplant Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Heart Transplant Recipients

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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No