Prospera Test Evaluation in Cardiac Transplant (ProTECT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- Natera, Inc.
- 入组人数
- 411
- 试验地点
- 1
- 主要终点
- Primary Endpoints:
研究概览
简要总结
The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation.
详细描述
The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera™ testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation. Patients who are enrolled in this study should have blood drawn for Prospera™ testing at regular intervals per routine clinical care. Prospera™ test results and results of surveillance endomyocardial biopsies, laboratory testing, echocardiograms, angiography and hemodynamic monitoring performed to monitor cardiac status and for signs of transplant rejection, as well as medications and post-transplant re-vascularization and surgical procedures will be recorded in the electronic case report form (eCRF). Patient management decisions, even those informed by the Prospera™ test result, are made based on the individual judgment of the healthcare providers participating in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary Endpoints:
时间窗: 3 years
Primary molecular endpoint: percent of donor-derived cell-free DNA (dd-cfDNA) measured via the Prospera™ test. Primary clinical endpoints: 1. Biopsy-proven rejection (ISHLT Grade ACR \>1R and ISHLT Grade AMR \>0). 2. Rejection with hemodynamic compromise (ejection fraction \<40% or \>20% decline from baseline or the need for inotropic agents in the absence of biopsy-proven rejection). 3. Treated rejection (biopsy proven rejection or hemodynamic compromise rejection where immunosuppressive therapy was increased or augmented).
次要结局
- Secondary Endpoints(3 years)
