Recruiting

cfDNA-MMDx

Sponsor:

University of Alberta

Code:

NCT04707872

Conditions

Heart Transplant Rejection

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

MMDx diagnostic test

Prospera

HLA antibody

Study Details

Brief 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.

Conditions

Heart Transplant Rejection

Study ID

NCT04707872

Start date

Jun 1, 2021

Status verified date

Jun, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Heart transplant protocol and for cause biopsies

The study population includes patients with a functioning heart transplant undergoing a biopsy for clinical indications as standard of care, or protocol biopsies of heart in high-risk patients, or follow-up after treatment.

Interventions

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

Primary outcome measure

  • Calibration of Prospera test for T cell-mediated rejection [ Time Frame: 18 months ]
  • Calibration of Prospera test for antibody-mediated rejection [ Time Frame: 18 months ]
  • Calibration of Prospera test for heart injury [ Time Frame: 18 month ]
  • Report calibrated Prospera test results for rejection [ Time Frame: 6 months ]
  • Report calibrated Prospera test results for heart injury [ Time Frame: 6 month ]

Central Contacts and Locations

Central contacts

Konrad Famulski, PhD

1 780 782 9463konrad@ualberta.ca

Robert Polakowski, PhD

1 780 492 5091polakows@ualberta.ca

Locations

Baptist Health Institute for Research and Innovation

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Victoria McIntosh Marren

victoria.mcintosh@baptist-health.org

Principal Investigator:

Patrick Campbell, MD

Tampa General Hospital, 409 Bayshore Blvd.

Recruiting

Tampa, Florida, United States, 33606

Contacts

Kristyn Kuzianik

kkuzianik@tgh.org

Principal Investigator:

Benjamin Mackie, MD

Columbia University Medical Center, Columbia Interventional Cardiovascular Care

Recruiting

West New York, New Jersey, United States, 10032

Contacts

Maria Alejandra Muñoz Cifuentes

mam2649@cumc.columbia.edu

Principal Investigator:

Gabriel Sayer, MD

Montefiore Medical Center, 3319 Rochambeau Avenue, 2nd FL

Recruiting

The Bronx, New York, United States, 10467

Contacts

Renae Robinson

rerobins@montefiore.org

Brandon Johnson

brajohnson@montefiore.org

Principal Investigator:

Omar Saeed, MD

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

Recruiting

Dallas, Texas, United States, 75246

Contacts

Aayla K Jamil, MBBS

Aayla.Jamil@BSWHealth.org

Principal Investigator:

Shelley Hall, MD

Cardiovascular Medicine, University of Utah Health

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Jennifer Hong

Jennifer.Hong@hsc.utah.edu

Principal Investigator:

Josef Stehlik, MD, PhD

Division of Cardiology, University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2R7

Contacts

Daniel Kim, MD

dk@ualberta.ca

Principal Investigator:

Daniel Kim, MD

More Information

Sponsor

University of Alberta

Last update posted

Jun 2, 2026

Last verified

Jun, 2026

Keywords

  • Donor derived cfDNA
  • gene expression
  • heart transplant biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-06-02.