Evaluating donor-derived DNA levels in heart transplant rejection
Official title: Trifecta-Heart cfDNA-MMDX Study: Comparing the DD-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test
Run by University of Alberta · NCT04707872 · Data updated 2026-11-12
This study is testing whether measuring donor DNA in the blood can help doctors better understand and detect heart transplant rejection in patients who are already having biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | University of Alberta Academic / other |
| Locations | 12 sites (Little Rock, Arkansas and 11 other locations) |
| Status | Recruiting |
| Started | June 1, 2021 |
| Main results expected | December 2027 |
| Study ends | July 2028 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT04707872 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are heart transplant recipients who are undergoing biopsies for clinical indications.
✕Probably not a fit
Patients who decline participation or are unable to provide informed consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the relationship between donor-derived cell-free DNA (DD-cfDNA) levels and HLA antibodies in heart transplant recipients. It will utilize the Molecular Microscope® Diagnostic System (MMDx) to assess gene expression features related to rejection and injury in heart transplants. The study will calibrate the Natera Inc DD-cfDNA Prospera® test against MMDx results to improve the accuracy of rejection assessments, which currently rely on endomyocardial biopsies that have high error rates. Participants will include heart transplant recipients undergoing clinically indicated biopsies.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and less invasive methods for monitoring heart transplant rejection.
How similar studies have gone: Previous studies have shown success with similar approaches in kidney transplants, but this specific application in heart transplants is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Baptist Health Institute for Research and Innovation
Little Rock, Arkansas, United States Recruiting -
Tampa General Hospital, 409 Bayshore Blvd.
Tampa, Florida, United States Recruiting -
Columbia University Medical Center, Columbia Interventional Cardiovascular Care
West New York, New Jersey, United States Recruiting -
Montefiore Medical Center, 3319 Rochambeau Avenue, 2nd FL
The Bronx, New York, United States Recruiting -
Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research Institute
Dallas, Texas, United States Recruiting -
Cardiovascular Medicine, University of Utah Health
Salt Lake City, Utah, United States Recruiting
Show 6 more locations
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Division of Cardiology, University of Alberta
Edmonton, Alberta, Canada Recruiting -
Institute for Clinical and Experimental Medicine - IKEM Videnska 1958/9
Prague, Czechia Recruiting -
Silesian Center for Heart Diseases (Ś!ąskie Centrum Chorób Serca w Zabrzu
Zabrze, Poland Recruiting -
Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute
Darlinghurst, Australia Not yet recruiting -
Heart Failure and Heart Transplant Unit, University of Bologna
Bologna, Italy Not yet recruiting -
Advanced Heart Failure Transplant Unit
A Coruña, Spain Not yet recruiting
Study contacts
- Principal investigator: Philip F Halloran, MD PhD — Alberta Transplant Applied Genomics Center, University of Alberta
- Study coordinator: Konrad Famulski, PhD
- Email: konrad@ualberta.ca
- Phone: 1 780 782 9463
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Nationwide Swedish program testing donor-derived cell-free DNA to monitor rejection after heart transplant
This project tests whether a blood test measuring donor-derived cell-free DNA can help monitor rejection in adults who have had a heart transplant.
-
Evaluating microvascular resistance in heart transplant patients
This study tests if measuring blood flow in the small vessels of heart transplant patients can help reduce the need for repeated heart tissue tests.
-
Using mobile video to help young heart transplant patients take their medications
This study tests whether using mobile videos can help young heart transplant patients remember to take their medications regularly.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.