The Levels of Fibrosis Biomarkers in Patients After Renal Transplantation in Relation to Arteriovenous Fistula Function
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Quality of life with EQ-5D-5L
研究概览
简要总结
The aim of the project is to assess the effect of functioning AVF in renal transplant patients on fibrosis, inflammation and LVH indicators. Clinical and laboratory parameters will be compared in a group of 150 patients, 75 patients with a functioning fistula and 75 patients with inactive vascular access. We will assess the impact of functional AVF and the levels of biomarkers on the survival of patients and transplanted kidneys.
详细描述
Patients after kidney transplantation during a routine visit will be asked to participate to the study. In eligible a number of studies will be conducted:
- detailed clinical examination
- routine laboratory tests
- lung ultrasound
- muscle strength with a dynamometer
- ultrasound assessment of upper limb vessels with assessment of fistula function (in the case of active fistula) and for the possibility of future vascular access
- blood collection and protection (10-15 ml) for biomarkers
- survey EQ-5D-5L and LVD-36
- functional strength test.
The obtained clinical data and test results will be subject to statistical analysis after anonymization. The impact of individual parameters on long-term prognosis will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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 old
- •kidney transplant
- •>12 months after transplantation
- •stable transplanted kidney function
- •signed informed consent
排除标准
- •GFR <15 ml / min
- •severe infection within 3 months of testing
- •increase in creatinine concentration> 0.5 mg / dl within 3 months before the test
- •active cancer
- •signs of severe heart failure (NYHA IV)
结局指标
主要结局
Quality of life with EQ-5D-5L
时间窗: Baseline visit up to 12 months
The survey results will be compared between the study and control groups to see if the presence of the arteriovenous fistula affects quality of life.
Prognostic value of biomarkers (NT-proBNP, Il-6, sST2, galectin-3, GDF-15, MMP7, TIMP1)
时间窗: Baseline visit and up to 12 months
The levels of biomarkers will be measured and the results will be compared between the study and control groups. A prognostic value of the biomarkers will be estimated.
次要结局
- Hospitalization-free survival(Up to 12 months from baseline visit)