BIIR Gene to Manage Heart Allograft Patients

Completed

• Conditions: Cardiac Transplant Failure

• Registration Number: NCT01929785
• Lead Sponsor: Baylor Research Institute

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

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-08-23
• Study First Posted: 2013-08-28
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To systematically collect blood samples from heart allograft recipients who are 0-2 years post-transplant to create a repository for genomic research.	2 years	To systematically collect blood samples from heart allograft recipients who are 0 -2 years post-transplant for eventual screening of blood cell gene activity, in order to identify diagnostically useful biomarkers that can help distinguish among multiple possible clinical presentation, e.g., acute rejection, antibody mediated rejection, infection, coronary artery disease, a variety of potential causes for heart dysfunction.).

Secondary Outcome Measures

Name	Time	Method
Recent work using our gene expression profiling (GEP) has shown that peripheral blood cells display a unique GEP that is 90% accurate for detection of acute rejection in liver transplant patients & hopefully hearts as well.	2 years	Recent work using our gene expression profiling (GEP) has shown that peripheral blood cells display a unique GEP that is 90% accurate for detection of acute rejection in liver transplant patients. The Investigators hypothesize that heart allograft recipients will display a similar pattern (Aim #2). The Investigators will retrospectively select longitudinal samples collected in Aim #1 from patients who did not experience rejection and from those who did, in order to determine if their GEP correlates with what we have observed for liver patients.

Trial Locations

Locations (1)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States