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NCAMR-CAMR Allosure Study

NCT04217343 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-08-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Tampa General Hospital

    lead OTHER

Principal Investigators

  • Benjamin Mackie, MD · Tampa General Hospital/Tampa General Medical Group

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-05
Primary Completion
2023-03-05
Completion
2023-03-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04217343 on ClinicalTrials.gov