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RECRUITING
NCT04707872

Trifecta-Heart cfDNA-MMDx Study

Sponsor: University of Alberta

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2021-06-01

Completion Date

2027-07

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

MMDx diagnostic test

Microarray test of gene expression in heart biopsies

DIAGNOSTIC_TEST

Prospera

Donor derived cell-free DNA in patient blood

DIAGNOSTIC_TEST

HLA 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