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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCardiology Research UBC

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Heart transplant recipients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 1 trial group
Group A: Heart Transplant Recipients

Trial outcomes

Primary outcomes

1

Number of avoided endomyocardial biopsies

Number of avoided endomyocardial biopsies because of HeartCare test integration

Time frame
12 Months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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