The Impact of Ezetimibe on Biochemical Markers of Cardiovascular Risk in Kidney Transplant Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Decrease of LDL cholesterol concentration.
研究概览
简要总结
In kidney transplant patients atherosclerosis process is accelerated even in asymptomatic patients. This is mainly the consequence of immunosuppressive therapy. Dyslipidemia is treated with statins in low doses only as high doses can lead to rhabdomyolysis and are therefore contraindicated. As second lipid lowering agent most commonly ezetimibe is used. The investigators hypothesise that ezetimibe as a second lipid lowering drug in kidney transplant patients lowers LDL cholesterol for additional 10 per cent.
详细描述
In addition to observing the lipid profile the investigators intend to look for other pathophysiological effects of ezetimibe, such as its influence on oxidative stress, endothelial function and inflammatory biochemical markers.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LDL > 2.5 mM, Already treated with statin, Stable renal function of various GFR, Men or women older than 18 years, Signed informed consent.
排除标准
- •Acute heart disease or any heart disease in the last 3 months, kidney graft failure, active systemic inflammatory disease, active malignant disease, chronic diarrhea and malabsorption, transaminases increased > 3 fold, creatin kinase increased > 5 fold, hypersensitivity reactions, active peptic ulcer disease.
研究组 & 干预措施
Ezetimibe, dyslipidemia, kidney transplant
干预措施: Ezetimibe (Drug)
结局指标
主要结局
Decrease of LDL cholesterol concentration.
时间窗: At enrolment, at three, six and nine months thereafter.
The investigators expect the LDL cholesterol concentration to lower for at least 10%.
次要结局
- Change in oxidative markers(At enrolment, at three, six and nine months thereafter.)
研究者
Gregor Mlinsek
MD PhD
University Medical Centre Ljubljana