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临床试验/NCT03227055
NCT03227055已完成不适用

Cardiovascular Comorbidity in Children With Chronic Kidney Disease: Identification of Novel Biomarkers and Therapeutic Targets

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2016年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
155
试验地点
1
主要终点
Hypertension

研究概览

简要总结

This 3-year study will systematically evaluate the prevalence, clinical symptoms, and progression of CV and kidney disease and assess the impact of potential genetic, pharmacological, behavior, and environmental risk factors in a prospective cohort with a sample size of 125 aged 3-18 years children with stage G1-G4 chronic kidney disease (CKD). Measurements of morphological (e.g., LVMI & cIMT) and functional characteristics (e.g., FMD & PWV) of the cardiovascular system and 24hr ABPM profile will serve as surrogate end points for CV comorbidity in this study. Possible associations of these end points with multiple molecular (ADMA & urine exosome miRNA), perceived value and behavior (EQ-5D-Y), pharmacological (NHIRD and CGRD), and environmental risk factors (patient and family survey) will be explored.

详细描述

Taiwan has the highest incidence and prevalence rates of end-stage renal disease all over the world. Chronic kidney disease (CKD) becomes a global public health burden, which can begin in earliest childhood. CKD in childhood differs from that in adults. Congenital anomalies of the kidney and urinary tract (CAKUT) is the leading cause of childhood CKD. Children with CKD due to CAKUT have the highest risk of having a genomic imbalance. Thus, early identification of genotype-phenotype correlations to develop novel therapeutic approaches might reduce the heavy burden of CKD for the future of Taiwan.

Study design:

  1. A 3-year prospective cohort study.

  2. Sample size: 125 children and adolescents with stage G1-G4 CKD, age 3 to 18 yr, and 30 controls.

  3. Measurement: Measurements of morphological (e.g., LVMI & cIMT) and functional characteristics (e.g., FMD & PWV) of the cardiovascular system and 24hr ABPM profile will serve as surrogate end points for CV comorbidity in this study. Possible associations of these end points with multiple molecular (ADMA & urine exosome miRNA), perceived value and behavior (EQ-5D-Y), pharmacological (NHIRD and CGRD), and environmental risk factors (patient and family survey) will be explored.

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
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children and adolescents with stage G1-G4 CKD

排除标准

  • current pregnancy
  • inability to complete major data collection
  • kidney transplant

结局指标

主要结局

Hypertension

时间窗: 1 year

Abnormal ABPM profile

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tain, You-Lin

Professor

Chang Gung Memorial Hospital

研究点 (1)

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