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Blood tests could spare heart transplant patients invasive biopsies

NCT ID NCT07819292

Diagnosis Sponsor: Cardiology Research UBC Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Running, but no longer taking on new participants.
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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 Results may not be published yet.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)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

After a heart transplant, doctors routinely take small tissue samples from the heart to check for rejection. This trial tests whether two blood tests, AlloMap and AlloSure, can safely replace some of those biopsies. Researchers will enroll 30 adults who had a heart transplant at St. Paul's Hospital in Vancouver within the past year. The goal is to see how many biopsies can be avoided by using the blood tests instead.

What this could mean

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

Active substance
HeartCare blood tests (AlloMap and AlloSure) used to monitor heart transplant rejection
What this could lead to
If it works, heart transplant patients could need fewer invasive biopsies, making follow-up care less uncomfortable and possibly safer.
What could go wrong
This is a small study of 30 people at one hospital. The blood tests may not reliably detect rejection, and missing a rejection episode could be dangerous.

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 30 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2030

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

Heart transplant recipients

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: * Adult (age ≥ 18 years) at the time of transplant * Recipient of a heart transplant at St. Paul's Hospital * Within 1 year of heart transplantation * Followed at the Post-Transplant Clinic in Vancouver, BC * Clinically stable at the time of scheduled HeartCare surveillance (no active hemodynamic compromise or clinical suspicion of rejection at study visit) * Able to provide written informed consent Exclusion Criteria: * Unable to provide informed consent * High immunological risk at transplant: positive flow crossmatch at time of transplant, or donor-specific antibodies (DSA) detected at time of transplant * Multi-organ transplant recipient (e.g., heart-kidney, heart-liver) * Clinical instability: hemodynamic instability, sepsis, or active severe wound infection at the time of a scheduled surveillance visit * Prior severe acute cellular rejection (≥ 3R ISHLT grade) or prior antibody-mediated rejection (pAMR ≥ 2) during the study period * EMBx clinically indicated for suspected rejection at the time of a scheduled HeartCare visit (these recipients remain in the study but their visit is classified as a clinically-indicated EMBx, not a HeartCare visit)

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As listed by the trial registrant

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

Heart transplant recipient

How to take part

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  1. The official record

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