BIIR Gene to Manage Heart Allograft Patients

NCT ID: NCT01929785

Last Updated: 2016-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-11-30

Brief Summary

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.

Detailed 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

Conditions

Cardiac Transplant Failure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Pre and Post Transplant

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

No interventions assigned to this group

One year post transplant

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 73 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shelley Hall, MD

Role: STUDY_CHAIR

Baylor Health Care System

Locations

Baylor University Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

009-265

Identifier Type: -

Identifier Source: org_study_id