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临床试验/NCT05205551
NCT05205551进行中(未招募)不适用

Prospera Test Evaluation in Cardiac Transplant (ProTECT)

Natera, Inc.1 个研究点 分布在 1 个国家目标入组 411 人开始时间: 2021年10月1日最近更新:
适应症

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

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)

研究者

发起方
Natera, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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