HEART-BC: Heart Transplant Evaluation Using Advanced Rejection Monitoring Tools - British Columbia
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
- 否
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
Nima Moghaddam
Dr.
Cardiology Research UBC
