NCT04217343

NCAMR-CAMR Allosure Study

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Tampa General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Transplant Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Allosure/Allomap/Cytokines testing	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.

Timeline

• Start date: 2020-03-05
• Primary completion: 2023-03-05
• Completion: 2023-03-05
• First posted: 2020-01-03
• Last updated: 2022-08-22

Locations

1 site across 1 country: United States