Health TrialsbyHealthPanel

Trifecta-Heart cfDNA-MMDx Study

ConditionHeart Transplant Rejection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Alberta

About this trial

Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from heart transplants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All heart transplant recipients undergoing a biopsy for clinical indications and protocol biopsies, as determined by their physician or surgeon, will be eligible to enroll in the study.

Patients are enrolled based on standard of care biopsies, including surveillance biopsies in high-risk patients, with informed consent.

Disqualifiers

Patients will be excluded from the study if they decline participation

Are unable to give informed consent.

Recipients of multiple organs.

Trial population

The study population includes patients with a functioning heart transplant undergoing a biopsy for clinical indications or surveillance (protocol) biopsy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MMDx diagnostic test

    Diagnostic test

    Microarray test of gene expression in heart biopsies

  • Prospera

    Diagnostic test

    Donor derived cell-free DNA in patient blood

  • HLA antibody

    Diagnostic test

    Centralized measurement of HLA antibodies in patient blood

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Heart transplant protocol and for cause biopsies3 interventions

Trial outcomes

Primary outcomes

1

Calibration of Prospera test for T cell-mediated rejection

Set DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx. Calibration of DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx.

Time frame
18 months
2

Calibration of Prospera test for antibody-mediated rejection

Set DD-cfDNA test cut-off values against the probability of antibody-mediated rejection in the biopsy as reported by MMDx.

Time frame
18 months
3

Calibration of Prospera test for heart injury

Set DD-cfDNA test cut-off values against the probability of acute and chronic heart injury in the biopsy as reported by MMDx.

Time frame
18 month
4

Report calibrated Prospera test results for rejection

Obtain clinicians feedback

Time frame
6 months

Secondary outcomes

1

Determine if Prospera blood test can replace heart biopsy test

Obtain clinicians feedback

Time frame
6 month
2

Determine if Prospera blood test can replace follow up heart biopsy

Determine whether resolution of DD-cfDNA after treatment can monitor response to therapy and avoid follow-up biopsies

Time frame
6 month
3

Assessment of donor-specific antibody status

Report and compare the DSA status based on centralized and local HLA antibody measurement.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Natera, Inc.

Collaborator

One Lambda

Collaborator

Source ClinicalTrials.gov
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