Trifecta-Heart cfDNA-MMDx Study

NCT04707872 · tracked via the Priya Life Science Italy tracker

Sponsor

University of Alberta

Phase

Observational

Started

2021-06-01

Last updated

2026-06-02

Condition(s) studied

Heart Transplant Rejection

Investigational drug(s) / intervention(s)

MMDx diagnostic testProsperaHLA antibody

MMDx diagnostic test: Microarray test of gene expression in heart biopsies

Prospera: Donor derived cell-free DNA in patient blood

HLA antibody: Centralized measurement of HLA antibodies in patient blood

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Calibration of Prospera test for T cell-mediated rejection — 18 months
Set DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx. Calibration of DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx.
Calibration of Prospera test for antibody-mediated rejection — 18 months
Set DD-cfDNA test cut-off values against the probability of antibody-mediated rejection in the biopsy as reported by MMDx.
Calibration of Prospera test for heart injury — 18 month
Set DD-cfDNA test cut-off values against the probability of acute and chronic heart injury in the biopsy as reported by MMDx.
Report calibrated Prospera test results for rejection — 6 months
Obtain clinicians feedback
Report calibrated Prospera test results for heart injury — 6 month
Obtain clinicians feedback

Trial sites (12)

Facility	City	Region	Status
Baptist Health Institute for Research and Innovation	Little Rock	Arkansas	Recruiting
Tampa General Hospital, 409 Bayshore Blvd.	Tampa	Florida	Recruiting
Columbia University Medical Center, Columbia Interventional Cardiovascular Care	West New York	New Jersey	Recruiting
Montefiore Medical Center, 3319 Rochambeau Avenue, 2nd FL	The Bronx	New York	Recruiting
Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research Institute	Dallas	Texas	Recruiting
Cardiovascular Medicine, University of Utah Health	Salt Lake City	Utah	Recruiting
Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute	Darlinghurst	Australia	Not Yet Recruiting
Division of Cardiology, University of Alberta	Edmonton	Alberta	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

More University of Alberta trials in Italy

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Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04707872 on ClinicalTrials.gov ↗ ← All trials in Italy