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Blood test may spare heart transplant patients from painful biopsies

NCT ID NCT04707872

Diagnosis 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing whether a simple blood test called Prospera can detect heart transplant rejection as accurately as the current standard—a biopsy of the heart. Researchers will compare the blood test results with biopsy results and antibody levels in 300 heart transplant recipients. If the blood test works well, it could one day reduce the need for invasive procedures.

What this could mean

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

Active substance
Prospera blood test (donor-derived cell-free DNA)
What this could lead to
If successful, this could lead to a simple blood test that reduces the need for invasive heart biopsies to check for transplant rejection.
What could go wrong
This is an early-stage study focused on calibrating the test, not proving it works in practice. The blood test may not be accurate enough to replace biopsies.

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 300 people

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

Started

Jun 2021

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

The study population includes patients with a functioning heart transplant undergoing a biopsy for clinical indications or surveillance (protocol) biopsy.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * All heart transplant recipients undergoing a biopsy for clinical indications and protocol biopsies, as determined by their physician or surgeon, will be eligible to enroll in the study. * Patients are enrolled based on standard of care biopsies, including surveillance biopsies in high-risk patients, with informed consent. Exclusion Criteria: * Patients will be excluded from the study if they decline participation * Are unable to give informed consent. * Recipients of multiple organs.

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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.

Heart transplant rejection

How to take part

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

  1. The places running it

    12 sites in 7 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

    NOT_YET_RECRUITING

    A Coruña, Spain

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

    RECRUITING

    Dallas, Texas, 75246, United States

  • Baptist Health Institute for Research and Innovation

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute

    NOT_YET_RECRUITING

    Darlinghurst, NSW 2010, Australia

  • Cardiovascular Medicine, University of Utah Health

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • Columbia University Medical Center, Columbia Interventional Cardiovascular Care

    RECRUITING

    West New York, New Jersey, 10032, United States

  • Division of Cardiology, University of Alberta

    RECRUITING

    Edmonton, Alberta, T6G 2R7, Canada

  • Heart Failure and Heart Transplant Unit, University of Bologna

    NOT_YET_RECRUITING

    Bologna, 40138, Italy

  • Institute for Clinical and Experimental Medicine - IKEM Videnska 1958/9

    RECRUITING

    Prague, 140 21, Czechia

  • Montefiore Medical Center, 3319 Rochambeau Avenue, 2nd FL

    RECRUITING

    The Bronx, New York, 10467, United States

  • Silesian Center for Heart Diseases (Ś!ąskie Centrum Chorób Serca w Zabrzu

    RECRUITING

    Zabrze, 41-800, Poland

  • Tampa General Hospital, 409 Bayshore Blvd.

    RECRUITING

    Tampa, Florida, 33606, United States

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