NCAMR-CAMR Allosure Study

Tampa General Hospital (TGH)

Status: Invitation-only

Conditions: Transplant Failure

Treatments: Diagnostic Test: Allosure/Allomap/Cytokines testing

Study type: Observational

Funder types: Other

Identifiers

NCT04217343

19-0118

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have undergone Orthotopic Heart Transplantation who have pAMR1 rejection.

Exclusion criteria

• Subjects less than 18 years old

Trial design

30 participants in 2 patient groups

non-complement mediated pAMR(H+)

Treatment:

Diagnostic Test: Allosure/Allomap/Cytokines testing

complement mediated pAMR(I+)

Treatment:

Diagnostic Test: Allosure/Allomap/Cytokines testing