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.
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Trifecta-Heart cfDNA-MMDx Study
At a glance
Conditions
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.
Study leadership
- Philip F Halloran, MD PhD · PRINCIPAL_INVESTIGATOR · Alberta Transplant Applied Genomics Center, University of Alberta
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- 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