Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation

June 1, 2026 updated by: Philip Halloran, University of Alberta

Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation, a Multicenter Study (INTERHEART)

Demonstrate the impact of the Molecular Microscope Diagnostic System as the standard of care for heart transplant patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The current standard for biopsy-based diagnoses of rejection of heart transplants is the ISHLT classification from 2004, which represents a widely-used international consensus, based on morphological criteria of the cellular infiltrate within the myocardial specimen system with certainties and some arbitrary and blurred parameters. Recent data-driven approaches using molecular and conventional technologies indicate that this system produces incorrect diagnoses with potential harm to patients due to inappropriate treatment. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new diagnostic system - the Molecular Microscope® Diagnostic System (MMDx) that interprets biopsies in terms of their molecular phenotype, and combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. The MMDx developed first in kidney transplant biopsies because phenotypes are well established, will now be adapted to heart transplant endomyocardial biopsies (EMBs). The present study will develop a Reference Set of EMB, adapt the MMDx system to assess and report EMBs; and validate and refine this system in 900 unselected prospectively collected for clinical indications and a standard of care EMBs from North American and European Centers. In addition to demonstrating the real-time feasibility and potential value of this System in patient care, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback to improve its utility. We refine now our MMDx system using a new type of analysis (see primary outcome) and the resulting MMDx report. Currently, INTERHEART recruited 1912 biopsies from 1279 patients.

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Darlinghurst, Australia, NSW 2010
        • Recruiting
        • Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute
        • Contact:
        • Principal Investigator:
          • Peter MacDonald, MD
  • Austria
      • Vienna, Austria, A-1090
        • Recruiting
        • Department of Cardiac Surgery, Medical University of Vienna
        • Contact:
        • Principal Investigator:
          • Andreas Zuckerman, MD
        • Contact:
          • MD
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • Recruiting
        • Alberta Transplant Applied Genomics Center, University of Alberta
        • Contact:
        • Principal Investigator:
          • Philip F Halloran, MD PhD
      • Edmonton, Alberta, Canada, T6G 2R7
        • Completed
        • Division of Cardiology, University of Alberta
  • Czechia
      • Prague, Czechia, 14021
        • Recruiting
        • Institute for Clinical and Experimental Medicine - IKEM
        • Contact:
        • Principal Investigator:
          • Vojtech Melenovsky, MD, PhD
  • France
      • Paris, France, 75015
        • Completed
        • Service de Néphrologie-Dialyse Adultes , Hôpital Necker-Enfants Malades
  • Italy
      • Bologna, Italy, 40138
        • Completed
        • Heart Failure and Heart Transplant Unit, University of Bologna
  • Spain
      • A Coruña, Spain
        • Completed
        • Advanced Heart Failure Transplant Unit
  • United States
    • California
      • Los Angeles, California, United States, 90024
        • Completed
        • UCLA Medical Centre
      • Los Angeles, California, United States, 90048
        • Completed
        • Cedars-Sinai Heart Institute
    • Texas
      • Dallas, Texas, United States, 75246
        • Completed
        • Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research Institute
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Completed
        • Cardiovascular Medicine, University of Utah Health
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Completed
        • Virginia Commonwealth University, Division of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study aims to recruit 1200 biopsies from heart transplant patients for clinical indications and the standard of care biopsies.

Description

Inclusion Criteria:

  • biopsy for clinical indications

Exclusion Criteria:

  • no consent
  • pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assign molecular scores (probability) of T cell mediated rejection, antibody mediated rejection in heart transplant biopsies, in a reference set of 200 biopsies
Time Frame: 2 years
Create a molecular classifier that predicts antibody mediated and T cell mediated rejection, based on the archetypal analysis.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assign in real time (three working days upon biopsy receipt) molecular scores (probability) of T cell mediated rejection and antibody mediated rejection.
Time Frame: 1 year
The molecular phenotype of a newly acquired sample predicts the histologic and clinical features of this sample when compared to the reference set.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Philip F Halloran, MD PhD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimated)

February 1, 2016

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ATAGC 002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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