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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07819292

Acronym

HEART-BC

Enrollment

Registered

2026-09-14

Start date

2027-01-01

Completion date

2030-01-01

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplant Recipient

Keywords

HeartCare test

Brief 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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Number of avoided endomyocardial biopsies	12 Months	Number of avoided endomyocardial biopsies because of HeartCare test integration

Contacts

CONTACTAndrew Starovoytov, MD

a.starovoytov@ubc.ca6046822344

Outcome results