NCAMR-CAMR Allosure Study

• Conditions: Transplant Failure
• Interventions: Diagnostic Test: Allosure/Allomap/Cytokines testing

• Registration Number: NCT04217343
• Lead Sponsor: Tampa General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-31
• Study First Posted: 2020-01-03
• Study Start: 2020-03-05
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-22
• Primary Completion: 2023-03-05
• Study Completion: 2023-03-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• Subjects less than 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-complement mediated pAMR(H+)	Allosure/Allomap/Cytokines testing	-
complement mediated pAMR(I+)	Allosure/Allomap/Cytokines testing	-

Primary Outcome Measures

Name	Time	Method
The level of dd-cfDNA in non-compliment mediated pAMR1 (H+) and complement mediated pAMR1 (I+) heart transplant rejection will be measured.	2 years	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.

Secondary Outcome Measures

Name	Time	Method
The level of inflammatory cytokines in non-compliment mediated pAMR1(H+) and compliment mediated pAMR1(I+) heart transplant rejection will be measured.	2 years	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.
The presence of HLA antibodies (DSA's) and titer levels, autoantibodies and titer levels and coronary artery vasculopathy will be measured.	2 years	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.

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States