Unraveling Mechanism of Action of Extracorporeal Photopheresis in Heart and Lung Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- identification the primary mechanism of action of ECP in CLAD and CAV by analyzing biological markers (such as relative expression levels of microRNAs, potentially involved in immune regulation), associated to response to a 6 month-ECP treatment course
研究概览
简要总结
This is a prospective observational single center national study. Lung and heart transplant patients with a definite diagnosis of chronic lung allograft dysfunction (CLAD) or cardiac allograft vasculopathy (CAV) will be assigned for extracorporeal photopheresis (ECP) as per common clinical practice to a 6-month ECP cycle with the aim of limiting progression of organ dysfunction. The exact mechanisms of ECP in chronic rejection after lung and heart transplantation (CLAD and CAV) are elusive but it is thought to induce apoptosis of lymphocytes and to generate regulatory T cells, which modulate transplant immune rejection by a complex effect.
详细描述
The primary objective of the present study is to identify the biomarkers associated to response to ECP after 6 months of treatment.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
identification the primary mechanism of action of ECP in CLAD and CAV by analyzing biological markers (such as relative expression levels of microRNAs, potentially involved in immune regulation), associated to response to a 6 month-ECP treatment course
时间窗: After 6 months from ECP treatment
次要结局
- Correlation between up-regulation or down-regulation of miRNAs at 6 months of therapy respect to baseline and other immune variables (regulatory T cells activation and differentiation, inflammatory cytokines levels and presence of anti-HLA antibodies)(After 6 months of therapy)
- Evaluation the effectiveness of ECP(After 2 years of follow-up from ECP)
- Effect of ECP on progression of myocardial fibrosis evaluated at CMR(After 6 months of treatment)
- Effect of ECP on ventricular function evaluated at echocardiography(After 6 months of treatment)
- Trend of heart failure biomarkers (NT proBNP or BNP) after 6 months of treatment(After 6 months of treatment)
研究者
Claudia Del Fante
MD
Fondazione IRCCS Policlinico San Matteo di Pavia