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临床试验/NCT02527902
NCT02527902已完成不适用

Autonomic Nervous System (ANS) Analysis According to Different Renal Function Stage in Immunoglobin A (IgA) Nephropathy

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Standard deviation of all R-R intervals (SDNN)

研究概览

简要总结

The estimation of the cardiovascular risk in the general population must take into account small renal disturbances, as the microalbuminuria. Conversely certain parameters of the cardiovascular risk influence the evolution of renal diseases, for example the arterial high blood pressure.

The measure of the activity of the autonomous nervous system, and especially the quantification of its variability, is a means to estimate the cardiovascular risk. The investigators formulate the hypothesis that the variability of the autonomous nervous system is an additional clinical element for the evaluation of the evolutionary risk of renal diseases.

The aim of this study is to compare the variability of the autonomous nervous system during the various evolutionary stages of the renal disease.

The renal disease studied will be IgA nephropathy (IgNA). IgNA is a histologically defined glomerulonephritis (rela biopsy) by the presence of deposits immunoglobulin A (IgA) in the renal mesangium (at list 1+) by immunofluorescence.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • •diagnosis of IgNA biopsy-proven free, informed, express and written

排除标准

  • •IgNA secondary to Henoch-Schonlein purpura (HSP) or Systemic Lupus Erythematosus or alcoholic cirrhosis
  • •current kidney transplantation
  • •Hypertension treated or not,
  • •Diseases interfering with ANS analysis: cardiac arrhythmia, beta-blocker therapy

研究组 & 干预措施

IgAN with glomerular filtration rate (GFR) >90 ml/min/1.73 m2

Experimental

Measure of ANS by holter device in IgAN patients with glomerular filtration rate (GFR) >90 ml/min/1.73 m2

干预措施: Holter (Device)

IgAN with GFR 60-89 ml/min/1.73 m2

Experimental

Measure of ANS by holter device in IgAN patients with GFR 60-89 ml/min/1.73 m2

干预措施: Holter (Device)

IgAN with GFR 30-59 ml/min/1.73 m2

Experimental

Measure of ANS by holter device in IgAN patients with GFR 30-59 ml/min/1.73 m2

干预措施: Holter (Device)

IgAN with GFR 15-29 ml/min/1.73 m2

Experimental

Measure of ANS by holter device in IgAN patients with GFR 15-29 ml/min/1.73 m2

干预措施: Holter (Device)

IgAN with GFR < 15ml/min/1.73 m2

Experimental

Measure of ANS by holter device in IgAN patients with GFR < 15ml/min/1.73 m2.

干预措施: Holter (Device)

结局指标

主要结局

Standard deviation of all R-R intervals (SDNN)

时间窗: day 1

Comparison of Standard deviation of all R-R intervals (SDNN) between GFR category of IgNA

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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