Heart Transplant RecipientHEART-BCNCT07819292
HEART-BC: Heart Transplant Evaluation Using Advanced Rejection Monitoring Tools - British Columbia
An observational study of Heart Transplant Recipient, run by Cardiology Research UBC.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant Recipient
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jan 2030
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart transplant recipients
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Heart Transplant Recipient
- Keywords
- HeartCare test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart Transplant Recipients | Prospective Heart Transplant Recipients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of avoided endomyocardial biopsies
Number of avoided endomyocardial biopsies because of HeartCare test integration
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant RecipientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Cardiology Research UBC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nima Moghaddam, Cardiology Research UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819292
- Sponsor's protocol ID
- H26-02794
- Acronym
- HEART-BC
- Status last verified
- Aug 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEART-BC: Heart Transplant Evaluation Using Advanced Rejection Monitoring Tools - British Columbia
- ClinicalTrials.gov ID
- NCT07819292
- Acronym / sponsor ID
- HEART-BC / H26-02794
- Conditions
- Heart Transplant Recipient
- Keywords
- HeartCare test
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cardiology Research UBCUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Transplant Recipients | – | –Prospective Heart Transplant Recipients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart transplant recipients
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of avoided endomyocardial biopsies
Time frame: 12 Months
Number of avoided endomyocardial biopsies because of HeartCare test integration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant Recipient, run by Cardiology Research UBC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Starovoytov, MD (6046822344 ext. 2263803, a.starovoytov@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of avoided endomyocardial biopsies (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.