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NCT Number: NCT02670408

Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation

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

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Key information

Conditions

Cardiac Transplant Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute, Darlinghurst, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • biopsy for clinical indications

Exclusion criteria

  • no consent
  • pregnant women

Treatment and study plan

Endomyocardial biopsy

Procedure

One of several endomyocardial biopsy bites taken as the standard of care. We are asking now for two endomyocardial biopsy bites, to determine tissue sampling variability.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Konrad S Famulski, PhD

CONTACT

[email protected]

1 7804921725

Robert Polakowski, PhD

CONTACT

[email protected]

1780 492 5091

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2027
Study completion
2028
First posted
Feb 1, 2016
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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