Improving heart transplant diagnostics with a new molecular system
Official title: Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation, a Multicenter Study (INTERHEART)
Run by University of Alberta · NCT02670408 · Data updated 2026-11-12
This study is testing a new diagnostic tool for heart transplant patients to see if it can better detect rejection compared to the usual methods.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | University of Alberta Academic / other |
| Locations | 13 sites (Los Angeles, California and 12 other locations) |
| Status | Recruiting |
| Started | January 2016 |
| Main results expected | December 2027 |
| Study ends | July 2028 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT02670408 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are heart transplant patients undergoing endomyocardial biopsy for clinical indications.
✕Probably not a fit
Patients who are pregnant or unable to provide consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to enhance the diagnosis of cardiac transplant rejection by implementing the Molecular Microscope Diagnostic System (MMDx) as a standard care tool for heart transplant patients. The MMDx system integrates molecular and histopathological features of endomyocardial biopsies (EMBs) along with clinical and laboratory data to provide a more accurate assessment compared to the traditional ISHLT classification. The study will involve the collection and analysis of 900 EMBs from various North American and European centers to validate and refine this innovative diagnostic approach.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of heart transplant rejection, improving patient outcomes and treatment decisions.
How similar studies have gone: Other studies have shown promise in using molecular diagnostics for organ transplantation, suggesting that this approach may lead to significant advancements in the field.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * biopsy for clinical indications Exclusion Criteria: * no consent * pregnant women
Where it's running
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Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute
Darlinghurst, Australia Recruiting -
Department of Cardiac Surgery, Medical University of Vienna
Vienna, Austria Recruiting -
Alberta Transplant Applied Genomics Center, University of Alberta
Edmonton, Alberta, Canada Recruiting -
Institute for Clinical and Experimental Medicine - IKEM
Prague, Czechia Recruiting -
UCLA Medical Centre
Los Angeles, California, United States Completed -
Cedars-Sinai Heart Institute
Los Angeles, California, United States Completed
Show 7 more locations
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Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research Institute
Dallas, Texas, United States Completed -
Cardiovascular Medicine, University of Utah Health
Salt Lake City, Utah, United States Completed -
Virginia Commonwealth University, Division of Cardiology
Richmond, Virginia, United States Completed -
Division of Cardiology, University of Alberta
Edmonton, Alberta, Canada Completed -
Service de Néphrologie-Dialyse Adultes , Hôpital Necker-Enfants Malades
Paris, France Completed -
Heart Failure and Heart Transplant Unit, University of Bologna
Bologna, Italy Completed -
Advanced Heart Failure Transplant Unit
A Coruña, Spain Completed
Study contacts
- Principal investigator: Philip F Halloran, MD PhD — University of Alberta
- Study coordinator: Konrad S Famulski, PhD
- Email: konrad@ualberta.ca
- Phone: 1 7804921725
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.