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New blood test could replace painful heart biopsies for transplant patients

NCT ID NCT03575910

Diagnosis Sponsor: University of British Columbia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new blood test called HEARTBiT that uses 9 RNA markers to detect acute rejection in heart transplant patients. Currently, rejection is found through frequent, invasive heart biopsies. The test was developed using samples from 150 patients and will be evaluated in 400 new patients across 5 centers. If successful, it could offer a faster, cheaper, and safer way to monitor transplant health.

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

196 people

The number who actually took part.

Started

Aug 2018

Finished

Mar 2026

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

It is anticipated that up to 400 heart transplant recipients will be enrolled as participants. Given the prevalence of treatable AR observed at the recruiting sites, 40-50 AR and 350 NR/MR are expected, excluding the time course (first year post-transplant) samples. Additionally, we plan on enrolling 30 normal control subjects. Comparisons will be made between AR, MR, and NR samples from independent patients.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Heart Transplant Subjects: Inclusion Criteria * recipients who are ≥ 19 years of age * willing and able to provide informed consent Exclusion Criteria * recipients under 19 years of age * recipients who have received multiple, different solid organ transplants (i.e. a heart and a kidney) * recipients who are HIV positive * recipients of organs from donors who test positive for HIV Normal Subjects: Inclusion Criteria * all individuals who are ≥ 19 years of age * willing and able to provide informed consent

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart disorder heart failure Rejection, Psychology transplant rejection

As listed by the trial registrant

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

Heart diseases Heart failure Heart failure, congestive Heart transplant failure and rejection Transplant failure Transplant, failure, heart

Contacts and locations

Locations

  • Ottawa Heart Institute

    Ottawa, Ontario, K1Y4W7, Canada

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Toronto General Hospital UHN

    Toronto, Ontario, M5G 2C4, Canada

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

More trials for these conditions

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