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NCT07819292
HEART-BC: Heart Transplant Evaluation Using Advanced Rejection Monitoring Tools - British Columbia
Conditions: Heart Transplant Recipient
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 30
Sponsor: Cardiology Research UBC
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
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT07819292). StuddyBuddy aggregates publicly available trial information.