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临床试验/NCT02992548
NCT02992548已完成4 期

Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease

Dong-A University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
62
试验地点
2
主要终点
mean change of erythrocyte membrane fatty acid including oleic acid

研究概览

简要总结

Treatment using statin has been decreased the risk of cardiovascular events in pre-dialysis CKD population. Supplementation with omega-3 fatty acid (FA) lowers the risk of cardiovascular death in patients with myocardial infarction. This cardioprotective effect of omega-3 FA can be explained by anti-inflammatory, anti-oxidative, or anti-thrombotic effects. Statin such as pravastatin is also known to have anti-inflammatory and antioxidant properties, suggesting that statin may replace the cardioprotective effect of omega-3 fatty acids. Erythrocyte membrane oleic acid is significantly higher in patients with acute coronary syndrome than control subjects. The cardioprotective effect of omega-3 FA may also be related to decreased oleic acid content of erythrocyte membrane. There is no report about the effect of statin on FA including erythrocyte membrane oleic acid. As omega-3 FAs are recognized as therapeutic agents for reducing triglycerides, statin may affect on the erythrocyte membrane FA. Therefore, pravastatin supplementation can modify erythrocyte membrane FA contents including oleic acid in CKD patients.

详细描述

Patients with chronic kidney disease (CKD) have higher risk of death and cardiovascular disease than general population. Treatment using statin has been decreased the risk of cardiovascular events in pre-dialysis CKD population. Supplementation with omega-3 fatty acid (FA) lowers the risk of cardiovascular death in patients with myocardial infarction. This cardioprotective effect of omega-3 FA can be explained by anti-inflammatory, anti-oxidative, or anti-thrombotic effects. Statin such as pravastatin is also known to have anti-inflammatory and antioxidant properties, suggesting that statin may replace the cardioprotective effect of omega-3 fatty acids.

Omega-3 FA such as EPA (eicosapentaenoic acid), DHA (docosahexaenoic acid), and EPA/arachidonic acid ratio are well known as key indicators of cardiovascular disease. In addition, erythrocyte membrane oleic acid is significantly higher in patients with acute coronary syndrome than control subjects. The cardioprotective effect of omega-3 FA may also be related to decreased oleic acid content of erythrocyte membrane. There is no report about the effect of statin on FA including erythrocyte membrane oleic acid. As omega-3 FAs are recognized as therapeutic agents for reducing triglycerides, statin may affect on the erythrocyte membrane FA. Therefore, pravastatin supplementation can modify erythrocyte membrane FA contents including oleic acid in CKD patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CKD patients who agreed with written informed consent
  • CKD patients who do not take statin
  • Who have LDL cholesterol over 100mg/dL and coronary vascular disease(CVD) or equivalent risk; Who have LDL cholesterol over 130mg/dL and two or more coronary vascular risk; Whose LDL cholesterol over 160mg/dL in patient with CKD stage 1 to 5 without dialysis.

排除标准

  • Patients with acute illness, a history of active infection, CVD, acute kidney injury during the past 3 months, or a history of malignancy or liver disease
  • Patients using statin, omega-3 fatty acid or sevelamer hydrochloride within 3 months
  • Patients who experienced side effects by statin treatment
  • Pregnant or pregnancy expected CKD patients
  • Patient with dyslipidemia due to nephrotic syndrome
  • Patient taken imaging study using contrast media during the past 14 days
  • Patient with albumin level < 3.0 g/dL

研究组 & 干预措施

pravastatin group

Experimental

Use of pravastatin 20mg to 40mg

干预措施: Pravastatin (Drug)

结局指标

主要结局

mean change of erythrocyte membrane fatty acid including oleic acid

时间窗: 24 weeks after intervention

次要结局

  • mean change of total cholesterol(24 weeks after intervention)
  • mean change of adiponectin(24 weeks after intervention)
  • mean change of triglyceride(24 weeks after intervention)
  • mean change of LDL-cholesterol(24 weeks after intervention)
  • mean change of HDL-cholesterol(24 weeks after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

WON SUK AN

Professor

Dong-A University

研究点 (2)

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