Trifecta-Heart cfDNA-MMDx Study for Heart Transplant Rejection

This observational study is looking at new ways to detect heart transplant rejection. Currently, doctors use biopsies (taking a small tissue sample) to check for rejection, but this can be imprecise. This study aims to see how well two newer diagnostic tests, Prospera and HLA antibody testing, compare to a more advanced biopsy analysis called MMDx. Prospera measures donor-derived cell-free DNA (DD-cfDNA) in your blood, which are tiny pieces of DNA from the transplanted heart. HLA antibody testing also uses a blood sample to look for specific antibodies. The study will enroll about 300 heart transplant recipients who are already having a biopsy for medical reasons. The main goal is to see how well the Prospera test can identify T cell-mediated rejection, antibody-mediated rejection, and heart injury, compared to the MMDx results, over 18 months.

Study design
This is an observational study with an unclear status, planning to enroll 300 participants. It is not a randomized trial.
What's involved
Participants will undergo standard of care biopsies and blood tests for Prospera and HLA antibody measurements.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for this study are measured at 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04707872

Trifecta-Heart cfDNA-MMDx Study

Recruiting
Not specifiedAll AgesObservational
University of Alberta
~300 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:MMDx diagnostic testProsperaHLA antibody

At a glance

Recruiting sites
9 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Calibration of Prospera test for T cell-mediated rejection
Measured over 18 months
+4 more outcomes measured
Heart Transplant Rejection

NCT04707872

Where you'd take part

This study runs at 12 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advanced Heart Failure Transplant Unit

    A Coruña, Spainstudy coordinator listed

    Not yet recruiting

  • Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research Institute

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Baptist Health Institute for Research and Innovation

    Little Rock, Arkansasstudy coordinator listed

    Recruiting

  • Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute

    Darlinghurst, Australiastudy coordinator listed

    Not yet recruiting

  • Cardiovascular Medicine, University of Utah Health

    Salt Lake City, Utahstudy coordinator listed

    Recruiting

  • Columbia University Medical Center, Columbia Interventional Cardiovascular Care

    West New York, New Jerseystudy coordinator listed

    Recruiting

  • Division of Cardiology, University of Alberta

    Edmonton, Alberta, Canadastudy coordinator listed

    Recruiting

  • Heart Failure and Heart Transplant Unit, University of Bologna

    Bologna, Italystudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Philip F Halloran, MD PhD · PRINCIPAL_INVESTIGATOR · Alberta Transplant Applied Genomics Center, University of Alberta

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Patients will be excluded from the study if they decline participation
Are unable to give informed consent.
Recipients of multiple organs.
  • Calibration of Prospera test for T cell-mediated rejection18 months

    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.

  • Calibration of Prospera test for antibody-mediated rejection18 months

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

  • Calibration of Prospera test for heart injury18 month

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

  • Report calibrated Prospera test results for rejection6 months

    Obtain clinicians feedback

  • Report calibrated Prospera test results for heart injury6 month

    Obtain clinicians feedback