Cardiac Transplant Failure
Conditions
Keywords
post tranplant heart allograft
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
Interventions
None listed
Sponsors
Baylor Research Institute
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 73 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| To correlate the BUMC GEP results with AlloMap results. | 2 years | To correlate the BUMC GEP results with with AlloMap results. The Investigators will retrospectively select longitudinal samples collected in Aim #1 from patients who had normal vs. high AlloMap scores |
| To determine whether immune response status, as reflected by donor specific antibody response adn Cylex ImmuKnow assay, alters the GEP in heart transplant patients. | 2 years | To determine whether immune response status, as reflected by donor specific antibody response and Cylex ImmuKnow assay, alters the GEP heart transplant patients. |
Countries
United States
Outcome results
None listed