NCAMR-CAMR Allosure Study

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Transplant Failure
• Intervention / Treatment: Diagnostic test: Allosure/Allomap/Cytokines testing

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone Orthotopic Heart Transplantation who have pAMR1 rejection will be included in the study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Subjects less than 18 years old

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-complement mediated pAMR(H+)	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.
complement mediated pAMR(I+)	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tampa General Hospital
• Investigators: Principal Investigator: Benjamin Mackie, MD, Tampa General Hospital/Tampa General Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2020
• Primary Completion (Anticipated): March 5, 2023
• Study Completion (Anticipated): March 5, 2023

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 31, 2019
• First Posted (Actual): January 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Heart
• Other Study ID Numbers: 19-0118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No