NCT00175149终止4 期
The Efficacy of 1,25 Dihydroxycholecalciferol on the Cardiovascular System in Patients With Renal Dysfunction
Per Ivarsen1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2002年1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
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The effect of dihydroxycholecalciferol on left ventricular hypertrophy
研究概览
简要总结
Left ventricular hypertrophy (LVH) predicts mortality at start of dialysis. Prevention of of LVH is important. It is not known whether secondary hyperparathyroidism might induce LVH. In the present study patients are randomised to 1.25 dihydroxycholecalciferol or no treatment to study the effect on LVH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic kidney disease (S-creatinin > 150 and < 600 mikroM)
- •Secondary hyperparathyroidism (Between 3-8 times the upper limit of our PTH assay)
- •Stable blood pressure during the last 6 months (less than (160/95)
- •B-hemoglobin > 6 mmol/l
- •EKG with sinus rhythm and no sign of Q-wave infarction
- •Expected follow up 6 month
排除标准
- •Pregnancy
- •Kidney transplantation
- •Malignant disease
研究组 & 干预措施
1
Active Comparator
Given alfacalcidiol. Dose adjusted after PTH level
干预措施: Alfacalcidiol (Drug)
结局指标
主要结局
The effect of dihydroxycholecalciferol on left ventricular hypertrophy
时间窗: 6 month
次要结局
- Changes in the activity of the renin-angiotensin system(6 month)
- Changes in left ventricular function(6 month)
研究者
Per Ivarsen
Consultant
Aarhus University Hospital
研究点 (1)
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