The TOGETHER Project - Heart

Heart Transplant Rejection Clinical Trial

— TOGETHER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833050
• Other study ID #: 17-000682
• Status: Completed
• Start date: December 7, 2017
• Est. completion date: September 22, 2020

Study information

• Verified date: June 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 22, 2020
• Est. primary completion date: September 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Transplant Rejection

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years

External Links

•   Mayo Clinic Clinical Trials