Validation of Heartsbreath Test for Heart Transplant Rejection
试验速览
- 阶段
- 不适用
- 入组人数
- 1,200
- 试验地点
- 5
- 主要终点
- To measure the sensitivity and specificity of the breath test as compared to the primary right ventricular endomyocardial biopsy for the development of an intrinsically safe, painless, and non-invasive detection technique.
研究概览
简要总结
The purpose of this study is to demonstrate and validate a breath test for detection of biomarkers of heart transplant rejection (Grade 2R heart transplant).
详细描述
This is a 36 month multi-center, open label, unblinded and blinded study on subjects have had a heart transplant within the previous 12 months and are scheduled to undergo an endomyocardial biopsy. The breath test will be performed to identify and validate the predicative algorithms that identify breath biomarkers for heart transplant rejection.
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
- •Subject is willing and able to cooperate with study, understand the scope of the study, and gives signed informed consent to participate.
- •Subject is the recipient of a heart transplant within the previous 12 months
- •Subject is scheduled for a routine endomyocardial biopsy
- •Subject is 18 years or older
排除标准
- •Evidence of acute intercurrent disease other than rejection reaction
结局指标
主要结局
To measure the sensitivity and specificity of the breath test as compared to the primary right ventricular endomyocardial biopsy for the development of an intrinsically safe, painless, and non-invasive detection technique.
时间窗: 60 days after completion
The current "gold standard" for heart transplant rejection diagnosis is a series of endomyocardial biopsies during the first twelve months after operation. This procedure is invasive, painful, and potentially hazardous. The Heartsbreath test is an intrinsically safe, painless, and non-invasive breath test for heart transplant rejection that employs volatile biomarkers of oxidative stress. The Food \& Drug Administration (FDA) approved the Heartsbreath test for clinical use with a Humanitarian Device Exemption (HDE).
次要结局
未报告次要终点