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OpenTrials
Completed

NCT Number: NCT03833050

The TOGETHER Project - Heart

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

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Key information

Conditions

Heart Transplant Rejection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. RNA-seq based peripheral blood assay in heart transplant recipients

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: TOGETHER

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2019
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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