Evaluating donor-derived DNA levels in heart transplant rejection
Trifecta-Heart cfDNA-MMDX Study: Comparing the DD-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test
University of Alberta · NCT04707872
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | University of Alberta (other) |
| Locations | 12 sites (Little Rock, Arkansas and 11 other locations) |
| Trial ID | NCT04707872 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are heart transplant recipients who are undergoing biopsies for clinical indications.
Not a fit: Patients who decline participation or are unable to provide informed consent will not benefit from this study.
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 performed: Previous studies have shown success with similar approaches in kidney transplants, but this specific application in heart transplants is novel.
Eligibility criteria
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 this trial is running
Little Rock, Arkansas and 11 other locations
- 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)
- Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute — Darlinghurst, Australia (NOT_YET_RECRUITING)
- Division of Cardiology, University of Alberta — Edmonton, Alberta, Canada (RECRUITING)
- Institute for Clinical and Experimental Medicine - IKEM Videnska 1958/9 — Prague, Czechia (RECRUITING)
- Heart Failure and Heart Transplant Unit, University of Bologna — Bologna, Italy (NOT_YET_RECRUITING)
- Silesian Center for Heart Diseases (Ś!ąskie Centrum Chorób Serca w Zabrzu — Zabrze, Poland (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Transplant Rejection, Donor derived cfDNA, gene expression, heart transplant biopsy