Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

900

participants targeted

Target at P75+ for all trials

Timeline

14mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach

7 countries

12 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11.5 years study duration

Study Progress90%

Jan 2016Jul 2027

Study Start

First participant enrolled

January 1, 2016

Completed

21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed

10 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed

10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

10.9 years

First QC Date

January 22, 2016

Last Update Submit

November 27, 2025

Conditions

Cardiac Transplant Disorder

Keywords

Heart transplantglobal gene expressionmolecular diagnostics

Outcome Measures

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
Create a molecular classifier that predicts antibody mediated and T cell mediated rejection, based on the archetypal analysis.
2 years

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.
1 year

Interventions

Endomyocardial biopsyPROCEDURE

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.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

biopsy for clinical indications

You may not qualify if:

no consent
pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Albertalead

Study Sites (13)

UCLA Medical Centre

Los Angeles, California, 90024, United States

COMPLETED

Cedars-Sinai Heart Institute

Los Angeles, California, 90048, United States

COMPLETED

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

Dallas, Texas, 75246, United States

COMPLETED

Cardiovascular Medicine, University of Utah Health

Salt Lake City, Utah, 84132, United States

COMPLETED

Virginia Commonwealth University, Division of Cardiology

Richmond, Virginia, 23298, United States

COMPLETED

Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute

Darlinghurst, NSW 2010, Australia

RECRUITING

Department of Cardiac Surgery, Medical University of Vienna

Vienna, A-1090, Austria

RECRUITING

Alberta Transplant Applied Genomics Center, University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

RECRUITING

Division of Cardiology, University of Alberta

Edmonton, Alberta, T6G 2R7, Canada

COMPLETED

Institute for Clinical and Experimental Medicine - IKEM

Prague, 14021, Czechia

RECRUITING

Service de Néphrologie-Dialyse Adultes , Hôpital Necker-Enfants Malades

Paris, 75015, France

COMPLETED

Heart Failure and Heart Transplant Unit, University of Bologna

Bologna, 40138, Italy

COMPLETED

Advanced Heart Failure Transplant Unit

A Coruña, Spain

COMPLETED

Related Publications (11)

Madill-Thomsen KS, Halloran PF. Precision diagnostics in transplanted organs using microarray-assessed gene expression: concepts and technical methods of the Molecular Microscope(R) Diagnostic System (MMDx). Clin Sci (Lond). 2024 Jun 5;138(11):663-685. doi: 10.1042/CS20220530.
PMID: 38819301BACKGROUND
Loupy A, Duong Van Huyen JP, Hidalgo L, Reeve J, Racape M, Aubert O, Venner JM, Falmuski K, Bories MC, Beuscart T, Guillemain R, Francois A, Pattier S, Toquet C, Gay A, Rouvier P, Varnous S, Leprince P, Empana JP, Lefaucheur C, Bruneval P, Jouven X, Halloran PF. Gene Expression Profiling for the Identification and Classification of Antibody-Mediated Heart Rejection. Circulation. 2017 Mar 7;135(10):917-935. doi: 10.1161/CIRCULATIONAHA.116.022907. Epub 2017 Feb 1.
PMID: 28148598RESULT
Halloran PF, Potena L, Van Huyen JD, Bruneval P, Leone O, Kim DH, Jouven X, Reeve J, Loupy A. Building a tissue-based molecular diagnostic system in heart transplant rejection: The heart Molecular Microscope Diagnostic (MMDx) System. J Heart Lung Transplant. 2017 Nov;36(11):1192-1200. doi: 10.1016/j.healun.2017.05.029. Epub 2017 May 29.
PMID: 28662985RESULT
Halloran PF, Reeve J, Aliabadi AZ, Cadeiras M, Crespo-Leiro MG, Deng M, Depasquale EC, Goekler J, Jouven X, Kim DH, Kobashigawa J, Loupy A, Macdonald P, Potena L, Zuckermann A, Parkes MD. Exploring the cardiac response to injury in heart transplant biopsies. JCI Insight. 2018 Oct 18;3(20):e123674. doi: 10.1172/jci.insight.123674.
PMID: 30333303RESULT
Parkes MD, Aliabadi AZ, Cadeiras M, Crespo-Leiro MG, Deng M, Depasquale EC, Goekler J, Kim DH, Kobashigawa J, Loupy A, Macdonald P, Potena L, Zuckermann A, Halloran PF. An integrated molecular diagnostic report for heart transplant biopsies using an ensemble of diagnostic algorithms. J Heart Lung Transplant. 2019 Jun;38(6):636-646. doi: 10.1016/j.healun.2019.01.1318. Epub 2019 Feb 6.
PMID: 30795962RESULT
Halloran PF, Madill-Thomsen KS. The Molecular Microscope Diagnostic System: Assessment of Rejection and Injury in Heart Transplant Biopsies. Transplantation. 2023 Jan 1;107(1):27-44. doi: 10.1097/TP.0000000000004323. Epub 2022 Dec 8.
PMID: 36508644RESULT
Halloran PF, Madill-Thomsen K, Mackova M, Aliabadi-Zuckermann AZ, Cadeiras M, Crespo-Leiro MG, Depasquale EC, Deng M, Gokler J, Hall SA, Kim DH, Kobashigawa J, Macdonald P, Potena L, Shah K, Stehlik J, Zuckermann A, Reeve J. Molecular states associated with dysfunction and graft loss in heart transplants. J Heart Lung Transplant. 2024 Mar;43(3):508-518. doi: 10.1016/j.healun.2023.11.013. Epub 2023 Nov 30.
PMID: 38042442RESULT
Halloran PF, Madill-Thomsen K, Aliabadi-Zuckermann AZ, Cadeiras M, Crespo-Leiro MG, Depasquale EC, Deng M, Gokler J, Kim DH, Kobashigawa J, Macdonald P, Potena L, Shah K, Stehlik J, Zuckermann A. Many heart transplant biopsies currently diagnosed as no rejection have mild molecular antibody-mediated rejection-related changes. J Heart Lung Transplant. 2022 Mar;41(3):334-344. doi: 10.1016/j.healun.2021.08.004. Epub 2021 Aug 26.
PMID: 34548198RESULT
Halloran PF, Madill-Thomsen K, Aliabadi-Zuckermann AZ, Cadeiras M, Crespo-Leiro MG, Depasquale EC, Deng M, Gokler J, Hall S, Jamil A, Kim DH, Kobashigawa J, Macdonald P, Melenovsky V, Patel J, Potena L, Shah K, Stehlik J, Zuckermann A. Redefining the molecular rejection states in 3230 heart transplant biopsies: Relationships to parenchymal injury and graft survival. Am J Transplant. 2024 Aug;24(8):1414-1426. doi: 10.1016/j.ajt.2024.03.031. Epub 2024 Mar 26.
PMID: 38527588RESULT
Madill-Thomsen KS, Reeve J, Aliabadi-Zuckermann A, Cadeiras M, Crespo-Leiro MG, Depasquale EC, Deng M, Goekler J, Kim DH, Kobashigawa J, Macdonald P, Potena L, Shah K, Stehlik J, Zuckermann A, Halloran PF. Assessing the Relationship Between Molecular Rejection and Parenchymal Injury in Heart Transplant Biopsies. Transplantation. 2022 Nov 1;106(11):2205-2216. doi: 10.1097/TP.0000000000004231. Epub 2022 Oct 21.
PMID: 35968995DERIVED
Halloran PF. Integrating molecular and histologic interpretation of transplant biopsies. Clin Transplant. 2021 Apr;35(4):e14244. doi: 10.1111/ctr.14244. Epub 2021 Feb 17. No abstract available.
PMID: 33595110DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy extract containing RNA

Study Officials

Philip F Halloran, MD PhD
University of Alberta
PRINCIPAL INVESTIGATOR

Central Study Contacts

Konrad S Famulski, PhD

CONTACT

1 7804921725 konrad@ualberta.ca

Robert Polakowski, PhD

CONTACT

1780 492 5091 polakows@ualberta.ca

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Distinguished Professor

Study Record Dates

First Submitted

January 22, 2016

First Posted

February 1, 2016

Study Start

January 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

December 1, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing: Will not share

Locations

US(5)AU(1)CZ(1)ES(1)IT(1)CA(2)FR(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (11)

Biospecimen

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations