NCAMR-CAMR Allosure Study

NCT04217343 | Unknown

• 1 other identifier: 19-0118
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplant Failure

Keywords

Heart

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 presence of HLA antibodies (DSA's) and titer levels, autoantibodies and titer levels and coronary artery vasculopathy will be measured.

  2 years

Study Arms (2)

non-complement mediated pAMR(H+)

Diagnostic Test: Allosure/Allomap/Cytokines testing

complement mediated pAMR(I+)

Diagnostic Test: Allosure/Allomap/Cytokines testing

Interventions

Allosure/Allomap/Cytokines testing DIAGNOSTIC_TEST

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+); non-complement mediated pAMR(H+)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Subjects less than 18 years old

Sponsors & Collaborators

• Tampa General Hospital: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Study Officials

• Benjamin Mackie, MD

  Tampa General Hospital/Tampa General Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator/Medical Doctor

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: January 3, 2020
• Study Start: March 5, 2020
• Primary Completion: March 5, 2023
• Study Completion: March 5, 2023
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)