BIIR Gene to Manage Heart Allograft Patients

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: Cardiac Transplant Failure

Study type: Observational

Funder types: Other

Identifiers

NCT01929785

009-265

Details and patient eligibility

About

This is a single center observational study. Duration of the study is 1 year. Participants will be followed in 2 groups. Group 1 will include all patients who have undergone a heart transplant, through the first year post transplant. Group 2 will include heart transplant recipients from 1 year to 2 years post transplant. Groups will be enrolled simultaneously. It is anticipated each group will have 25 participants.

Full description

Application of the BIIR gene expression profile approach to heart transplantation clinical diagnostic issues is likely to create new means to detect rejection at the earliest stages, to help prevent progression through earlier treatment, to discover new avenues targets for treatment of heart graft rejection, and to reduce the cost of post-transplant health care

Enrollment: 56 patients

Sex: All

Ages: 18 to 73 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who will have or have already received a heart transplant.
• Patients who have no other transplant history.
• Men and Women ages 18 to 73

Exclusion criteria

• Patients who are pregnant or lactating will not be eligible for this protocol.
• Patients who are cognitively impaired

Trial design

56 participants in 2 patient groups

Pre and Post Transplant

Description:

Research blood samples will be drawn pre-transplant, and at monthly post transplant visits at times corresponding to post-transplant, standard of care ImmKnowo and AlloMap clinical testing. A minimum of 12 visits per patient is expected

One year post transplant

Description:

The second group will include heart transplant recipients at one year post transplant who consent to participate in the study. Research blood samples will be drawn at quarterly post transplant visits (standard of care in Year 2 post transplant) corresponding to ImmunKnow and AlloMap testing. A minimum of 4 visits per patient is expected.