ClinicalTrials.gg
Not yet recruitingNCT07819292HEART-BCUpdated Sep 14, 2026

HEART-BC: Heart Transplant Evaluation Using Advanced Rejection Monitoring Tools - British Columbia

An observational study in Heart Transplant Recipient, sponsored by Cardiology Research UBC. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Cardiology Research UBC · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

Evaluate whether integration of HeartCare (AlloMap + AlloSure) into routine post-transplant surveillance reduces the number of invasive endomyocardial biopsies (EMBx) in the first year post-transplant

Read the detailed description

While HeartCare has demonstrated efficacy in large U.S.-based registries and has been incorporated into routine post-transplant surveillance at many U.S. centres, its feasibility and clinical utility within a Canadian tertiary heart transplant program have not been prospectively evaluated. The University of Toronto has utilized HeartCare within its transplant program for several years, supported through charitable funding; however, to our knowledge, there has been no prospective evaluation or published analysis of its implementation, impact on biopsy utilization, or healthcare resource use in the Canadian setting. This represents an important evidence gap that the proposed study is uniquely positioned to address.

BC's centralised, single-centre transplant programme at SPH - with a defined annual transplant volume and established relationships with CareDx - provides an ideal setting for a feasibility study. Demonstrating successful integration of HeartCare into routine BC transplant surveillance will provide the evidence base to support broader adoption, justify provincial funding, and contribute to the generalisability of HeartCare's clinical benefits in a Canadian context.

02

Conditions studied

  • Heart Transplant Recipient

Keywords

  • HeartCare test
03

In context

Lead sponsor

Cardiology Research UBC is the lead sponsor of 18 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Heart transplant recipients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • Unable to provide
  • 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • Heart Transplant Recipients

    Prospective Heart Transplant Recipients

06

What researchers measure

Primary outcomes

  1. Number of avoided endomyocardial biopsies

    Number of avoided endomyocardial biopsies because of HeartCare test integration

    Time frame: 12 Months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Jan 2030, 36 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2026
First posted
Sep 14, 2026
StartEst.
Jan 1, 2027
Primary completionEst.
Jan 1, 2030
CompletionEst.
Jan 1, 2030
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07819292
Lead sponsor
Cardiology Research UBC
Responsible party
Nima Moghaddam (Dr., Cardiology Research UBC) — Principal investigator
First posted
Sep 14, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Jan 1, 2030 (estimated)
Completion
Jan 1, 2030 (estimated)
Last update
Sep 14, 2026

Study contacts

Andrew Starovoytov, MD
Contact
a.starovoytov@ubc.ca
6046822344 ext. 2263803

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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