Trifecta-Heart cfDNA-MMDx Study

Recruiting now

Conditions studied: Heart Transplant Rejection

In brief

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.

Key facts

Study ID

NCT04707872

Run by

University of Alberta

People needed

300

Starts

2021-06-01

Expected to finish

2028-07-01

Last updated by the study team

2026-06-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients will be excluded from the study if they decline participation
• Are unable to give informed consent.
• Recipients of multiple organs.

Where it is running

• Columbia University Medical Center, Columbia Interventional Cardiovascular Care — West New York, New Jersey, United States (enrolling)
• Silesian Center for Heart Diseases (Ś!ąskie Centrum Chorób Serca w Zabrzu — Zabrze, Poland (enrolling)
• Baptist Health Institute for Research and Innovation — Little Rock, Arkansas, United States (enrolling)
• Montefiore Medical Center, 3319 Rochambeau Avenue, 2nd FL — The Bronx, New York, United States (enrolling)
• Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research Institute — Dallas, Texas, United States (enrolling)
• Cardiovascular Medicine, University of Utah Health — Salt Lake City, Utah, United States (enrolling)
• Tampa General Hospital, 409 Bayshore Blvd. — Tampa, Florida, United States (enrolling)
• Division of Cardiology, University of Alberta — Edmonton, Alberta, Canada (enrolling)
• Institute for Clinical and Experimental Medicine - IKEM Videnska 1958/9 — Prague, Czechia (enrolling)
• Advanced Heart Failure Transplant Unit — A Coruña, Spain
• Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute — Darlinghurst, Australia
• Heart Failure and Heart Transplant Unit, University of Bologna — Bologna, Italy

Full record on ClinicalTrials.gov

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