NCT01250405已完成4 期
Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients
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
- 23
- 试验地点
- 1
- 主要终点
- Arterial stiffness
研究概览
简要总结
The primary objective is to determine whether reduction of serum calcium concentration by cinacalcet leads to reduction of mean blood pressure adjusted c-fPWV. The secondary objectives are to study the effects of calcium reduction on 1) carotid-radial PWV (c-rPWV), 2) common carotid artery (CCA) biomechanics, 3) pulse wave profile and cardiac function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
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 (> 3 months) hemodialysis population of > 18 years old
- •PTH > 300 ng/L
- •corrected Ca > 2.10 mmol/L
- •stable hypertensive drugs (> 1 month)
- •stable doses of phosphate binders and dialysis calcium concentration
- •palpable femoral pulse
- •systolic BP of 90-180 mmHg
- •expected survival of > 6 months
排除标准
- •hemodialysis > 3 years
- •acute infection
- •history of myocardial infarction or stroke within the past 3 months
- •inability to consent
- •intolerance to cinacalcet
- •inadequate birth control
研究组 & 干预措施
Cinacalcet
Active Comparator
干预措施: Cinacalcet (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Arterial stiffness
时间窗: Arterial stiffness with be measured after 1 week with placebo and after 1 week with cinacalcet
次要结局
- Ventricular function(Ventricular function with be measured after 1 week with placebo and after 1 week with cinacalcet)
研究者
Karine Marquis
Professionnelle de recherche
Laval University
研究点 (1)
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