Biomarkers for Diagnosis, Prognosis, and Targeted Therapy After Heart Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Plasma donor-derived cell-free DNA (dd-cfDNA) for routine surveillance of acute rejection after heart transplantation
研究概览
简要总结
The objective of this prospective observational single center study is to investigate donor-derived cell-free DNA (ddcfDNA), peripheral blood platelet mRNA, peripheral blood extracellular vesicle mRNA, and peripheral blood leukocyte mRNA expression in recognition of clinically significant endomyocardial biopsy (EMB) proven acute rejection in human heart transplant recipients. In detail, the objective is to develop novel biomarkers and liquid biopsies for diagnosis, prognosis, and targeted molecular therapy for primary graft failure, ischemia-reperfusion injury, acute rejection, and development of late graft failure and cardiac allograft vasculopathy, and for monitoring immunosuppression after heart transplantation.
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
- 是
入选标准
- •patient age > 18 years
- •heart transplant recipient
- •has signed informed consent
排除标准
- •foreign residency
- •no signed informed consent collected
结局指标
主要结局
Plasma donor-derived cell-free DNA (dd-cfDNA) for routine surveillance of acute rejection after heart transplantation
时间窗: 5 years
To compare plasma dd-cfDNA to endomyocardial biopsy data
Allograft educated platelet-derived mRNA for gene expression profiling of acute rejection after heart transplantation
时间窗: 5 years
To compare gene expression profile of allograft-educated platelets to endomyocardial biopsy data
Plasma extracellular vesicle (EV) derived mRNA for gene expression profiling of acute rejection after heart transplantation
时间窗: 5 years
To compare gene expression profile of EV-derived mRNA to endomyocardial biopsy data
Plasma glycoproteins for routine surveillance of acute rejection after heart transplantation
时间窗: 5 years
To compare plasma glycoproteome profile to endomyocardial biopsy data
次要结局
- Plasma metabolomics changes during acute rejection after heart transplantation(1 year)
- Plasma metabolomics changes during the first year after heart transplantation and their relationship to the development of cardiac allograft vasculopathy(5 years)
- Plasma proteomics changes during acute rejection after heart transplantation(1 year)
- Peripheral blood mononuclear cell mRNA expression for gene expression profiling of acute rejection after heart transplantation(1 year)
- Plasma metabolomics changes during the first year after heart transplantation and their relationship to patient survival at 1, 3, and 5 years(5 years)
- Plasma proteomics changes during the first year after heart transplantation and their relationship to the development of cardiac allograft vasculopathy(5 years)
- Plasma proteomics changes during the first year after heart transplantation and their relationship to patient survival at 1, 3, and 5 years(5 years)
研究者
Karl Lemstrom
Professor of Cardiothoracic surgery
Helsinki University Central Hospital