NCAMR-CAMR Allosure Study

Study Overview
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Brief Summary
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Heart Transplant recipients at Tampa General Hospital heart transplant program who have pAMR1(H+) or pAMR1(I+) rejection will have a DD-cfDNA /GEP sample obtained at the time of the rejection. The DD-cfDNA/GEP will then be drawn every month post treatment for the rejection until the DD-cfDNA/GEP level returns to normal. A total of fifteen recipients with pAMR1(H+) and fifteen recipients with pAMR1(I+) rejection will be included in the study which will last two years. The presence of HLA antibodies (DSA's) and the titers, presence of Autoantibodies, the measurement of cytokines IL2, IL4, IL6, IL 10, IL 17, TNF alpha, TGF beta, the presence of coronary artery vasculopathy, the time from transplant to the onset of the episode of AMR, time to resolution, the response to treatment and comparison to the DD-cfDNA/GEP level with pAMR2 and pAMR 3 rejections will be analyzed.

Official Title
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NON-COMPLEMENT MEDIATED AMR vs. COMPLEMENT MEDIATED AMR: DOES DD-cfDNA/GEP SHOW A DIFFERENCE

Conditions
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Transplant Failure

Intervention / Treatment
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* Diagnostic Test: Allosure/Allomap/Cytokines testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have undergone Orthotopic Heart Transplantation who have pAMR1 rejection. Exclusion Criteria: Subjects less than 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| non-complement mediated pAMR(H+)<br> | Diagnostic Test: Allosure/Allomap/Cytokines testing<br>* All patients with evidence of Cardiac Transplant rejection will undergo Allosure, Allomap, and cytokine testing. Allosure and Allomap will be performed as part of routine care. Cytokine testing will be performed at time of rejection and resolution.<br>|
| complement mediated pAMR(I+)<br> | Diagnostic Test: Allosure/Allomap/Cytokines testing<br>* All patients with evidence of Cardiac Transplant rejection will undergo Allosure, Allomap, and cytokine testing. Allosure and Allomap will be performed as part of routine care. Cytokine testing will be performed at time of rejection and resolution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of dd-cfDNA in non-compliment mediated pAMR1 (H+) and complement mediated pAMR1 (I+) heart transplant rejection will be measured. | The level of dd-cfDNA in non-compliment mediated pAMR1 (H+) and complement mediated pAMR1 (I+) heart transplant rejection will be measured and then compared statistically to each other via Students t test as well as to the level of dd-cf DNA before and after the rejection episode. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of inflammatory cytokines in non-compliment mediated pAMR1(H+) and compliment mediated pAMR1(I+) heart transplant rejection will be measured. | The level of inflammatory cytokines in non-compliment mediated pAMR1(H+) and compliment mediated pAMR1(I+) heart transplant rejection will be measured and compared statistically to each other via the Students t test as well as to the level of inflammatory cytokines after the rejection episode has resolved. The cytokines that will be assessed are: IL2, IL4, IL6, IL10, IL17, TNF alpha and TGF beta. | 2 years | 
| The presence of HLA antibodies (DSA's) and titer levels, autoantibodies and titer levels and coronary artery vasculopathy will be measured. | The presence of HLA antibodies (DSA's) and titer levels, autoantibodies and titer levels and coronary artery vasculopathy will be measured in the heart transplant recipients with non-compliment mediated pAMR1(H+) and pAMR1(I+) rejection and compared to each other via Students t test. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart