RecruitingNot Applicable

Trifecta-Heart cfDNA-MMDx Study

United States300 participantsStarted 2021-06-01

Plain-language summary

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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Patients will be excluded from the study if they decline participation * Are unable to give informed consent. * Recipients of multiple organs.

What they're measuring

Calibration of Prospera test for T cell-mediated rejection

Timeframe: 18 months

Calibration of Prospera test for antibody-mediated rejection

Timeframe: 18 months

Calibration of Prospera test for heart injury

Timeframe: 18 month

Report calibrated Prospera test results for rejection

Timeframe: 6 months

Report calibrated Prospera test results for heart injury

Timeframe: 6 month

Trial details

NCT IDNCT04707872

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Konrad Famulski, PhD

1 780 782 9463 konrad@ualberta.ca

View on ClinicalTrials.gov More Heart Transplant Rejection trials