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NCAMR-CAMR Allosure Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217343
Recruitment Status : Enrolling by invitation
First Posted : January 3, 2020
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Mark Weston, 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.

Condition or disease Intervention/treatment
Transplant Failure Diagnostic Test: Allosure/Allomap/Cytokines testing

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: NON-COMPLEMENT MEDIATED AMR vs. COMPLEMENT MEDIATED AMR: DOES DD-cfDNA/GEP SHOW A DIFFERENCE
Actual Study Start Date : March 5, 2020
Estimated Primary Completion Date : March 5, 2022
Estimated Study Completion Date : March 5, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The level of dd-cfDNA in non-compliment mediated pAMR1 (H+) and complement mediated pAMR1 (I+) heart transplant rejection will be measured. [ Time Frame: 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 :
  1. The level of inflammatory cytokines in non-compliment mediated pAMR1(H+) and compliment mediated pAMR1(I+) heart transplant rejection will be measured. [ Time Frame: 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.

  2. The presence of HLA antibodies (DSA's) and titer levels, autoantibodies and titer levels and coronary artery vasculopathy will be measured. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have undergone Orthotopic Heart Transplantation who have pAMR1 rejection will be included in the study.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects less than 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217343


Locations
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United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
Sponsors and Collaborators
Mark Weston
Investigators
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Principal Investigator: Mark Weston, MD Tampa General Medical Group
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Responsible Party: Mark Weston, Principal Investigator, Tampa General Hospital
ClinicalTrials.gov Identifier: NCT04217343    
Other Study ID Numbers: 19-0118
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark Weston, Tampa General Hospital:
Heart