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临床试验/NCT07819292
NCT07819292尚未招募不适用

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

Cardiology Research UBC0 个研究点目标入组 30 人开始时间: 2027年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
主要终点
Number of avoided endomyocardial biopsies

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

Heart Transplant Recipients

Prospective Heart Transplant Recipients

结局指标

主要结局

Number of avoided endomyocardial biopsies

时间窗: 12 Months

Number of avoided endomyocardial biopsies because of HeartCare test integration

次要结局

未报告次要终点

研究者

发起方
Cardiology Research UBC
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nima Moghaddam

Dr.

Cardiology Research UBC

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