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New molecular test could spot heart transplant rejection faster

NCT ID NCT02670408

Knowledge-focused Sponsor: University of Alberta Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to see if a new molecular test can better detect rejection in heart transplant patients compared to standard biopsy analysis. Researchers will collect extra biopsy samples from 900 participants and analyze them using the Molecular Microscope Diagnostic System. The goal is to create a more accurate and timely tool for diagnosing rejection, potentially improving long-term outcomes for transplant recipients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a more accurate and faster way to detect rejection in heart transplant patients, potentially improving their care.
What could go wrong
This is an observational study, not a treatment trial. The new test may not prove more useful than current methods, and results may not change patient outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 900 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Jan 2016

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * biopsy for clinical indications Exclusion Criteria: * no consent * pregnant women

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Conditions

The condition(s) this trial relates to.

transplant rejection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac transplant disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Heart Failure Transplant Unit

    COMPLETED

    A Coruña, Spain

  • Alberta Transplant Applied Genomics Center, University of Alberta

    RECRUITING

    Edmonton, Alberta, T6G 2E1, Canada

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

    COMPLETED

    Dallas, Texas, 75246, United States

  • Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute

    RECRUITING

    Darlinghurst, NSW 2010, Australia

  • Cardiovascular Medicine, University of Utah Health

    COMPLETED

    Salt Lake City, Utah, 84132, United States

  • Cedars-Sinai Heart Institute

    COMPLETED

    Los Angeles, California, 90048, United States

  • Department of Cardiac Surgery, Medical University of Vienna

    RECRUITING

    Vienna, A-1090, Austria

  • Division of Cardiology, University of Alberta

    COMPLETED

    Edmonton, Alberta, T6G 2R7, Canada

  • Heart Failure and Heart Transplant Unit, University of Bologna

    COMPLETED

    Bologna, 40138, Italy

  • Institute for Clinical and Experimental Medicine - IKEM

    RECRUITING

    Prague, 14021, Czechia

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

    COMPLETED

    Paris, 75015, France

  • UCLA Medical Centre

    COMPLETED

    Los Angeles, California, 90024, United States

  • Virginia Commonwealth University, Division of Cardiology

    COMPLETED

    Richmond, Virginia, 23298, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.