RecruitingNCT04707872

Trifecta-Heart cfDNA-MMDx Study

Trifecta-Heart cfDNA-MMDX Study: Comparing the DD-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test

Sponsor

University of Alberta

Enrollment

300 participants

Start Date

Jun 1, 2021

Study Type

OBSERVATIONAL

Summary

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.

Eligibility

Inclusion Criteria2

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 Criteria3

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTMMDx diagnostic test

Microarray test of gene expression in heart biopsies

DIAGNOSTIC_TESTProspera

Donor derived cell-free DNA in patient blood

DIAGNOSTIC_TESTHLA antibody

Centralized measurement of HLA antibodies in patient blood

Locations(12)

Baptist Health Institute for Research and Innovation

Little Rock, Arkansas, United States

Tampa General Hospital, 409 Bayshore Blvd.

Tampa, Florida, United States

Columbia University Medical Center, Columbia Interventional Cardiovascular Care

West New York, New Jersey, United States

Montefiore Medical Center, 3319 Rochambeau Avenue, 2nd FL

The Bronx, New York, United States

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

Dallas, Texas, United States

Cardiovascular Medicine, University of Utah Health

Salt Lake City, Utah, United States

Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute

Darlinghurst, Australia

Division of Cardiology, University of Alberta

Edmonton, Alberta, Canada

Institute for Clinical and Experimental Medicine - IKEM Videnska 1958/9

Prague, Czechia

Heart Failure and Heart Transplant Unit, University of Bologna

Bologna, Italy

Silesian Center for Heart Diseases (Ś!ąskie Centrum Chorób Serca w Zabrzu

Zabrze, Poland

Advanced Heart Failure Transplant Unit

A Coruña, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04707872