BIIR Gene to Manage Heart Allograft Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Application of In-House Developed Nanomedicine Technology for Diagnosis and Management of Post-Transplant Heart Allograft Patients

Conditions
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Cardiac Transplant Failure

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 73 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre and Post Transplant<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To systematically collect blood samples from heart allograft recipients who are 0-2 years post-transplant to create a repository for genomic research. | 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.). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post tranplant heart allograft