Development of Non-invasive Cell-free DNA to Supplant Invasive Biopsy in Heart Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Natera, Inc.
- 入组人数
- 147
- 试验地点
- 9
- 主要终点
- Primary clinical endpoint*
研究概览
简要总结
This is a prospective, multicenter observational, unblinded, longitudinal cohort study. Subjects will be enrolled into the study prior to or at the time of heart transplantation. All subjects will follow the center's standard of care surveillance schedule. Blood samples will be collected for Prospera testing at the time any surveillance or for-cause testing, which may include endomyocardial biopsy (EMB), echocardiography or other cardiac imaging studies, and/or molecular testing, is performed.
详细描述
Subjects will undergo surveillance monitoring for rejection per the institution's standard clinical care schedule after transplant. Surveillance procedures may include EMB, imaging such as echocardiography, and/or molecular testing. Surveillance is expected to occur at this approximate schedule during the 12 months post-transplant:
- Weekly during month 1
- Every other week months 2-3
- Monthly during months 4-6
- Every 1-3 months during months 7-12
For-cause testing for rejection will be performed as clinically indicated and per the institution's standard clinical care. Prospera testing will be performed at the time each standard of care (SOC) rejection surveillance procedure and at the time of each for-cause testing for rejection. Prospera test results will be provided to the clinical team.
Additional blood samples for research only will be collected at the time of each Prospera blood sample collection. Results of testing performed on research blood samples will not be returned to investigators for use in clinical care.
Study central laboratory or central review for research purposes will include:
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
- •Age 18 years or older at the time of signing informed consent.
- •Undergoing transplant evaluation or currently on the heart transplant waiting list and expected to receive a heart transplant.
- •Able to read, understand, and provide written informed consent.
- •Able and willing to comply with the study visit schedule, study procedures, and study requirements.
排除标准
- •Concurrent multiple solid organ or tissue transplants.
- •Prior history of any organ or cellular transplantation.
结局指标
主要结局
Primary clinical endpoint*
时间窗: 12 months
Incidence of the composite endpoint of treated rejection, graft dysfunction, re-transplantation, or death at 12 months after transplant. \*Clinical endpoints are defined as follows: 1. Treated rejection: treated biopsy proven rejection (ISHLT ACR Grade ≥ 2R or AMR Grade ≥ pAMR1) or biopsy-negative rejection treated with pulse-dose steroids, monoclonal antibodies, plasmapheresis and/or intravenous immunoglobulin (IVIg). 2. Graft dysfunction: left ventricular ejection fraction (LVEF) decline \>10% from baseline and \< 50% absolute LVEF by echocardiography. 3. Re-transplantation: being listed for re-transplant or being re-transplanted. 4. Death due to any cause.
Primary Molecular Endpoint
时间窗: 1 year
Percent and quantity of donor-derived cell-free DNA (dd-cfDNA) measured via the Prospera test.
次要结局
- Secondary Endpoints(12 months)