Effect of Cinacalcet Treatment on Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Aortic pulse wave velocity after the cinacalcet treatment
研究概览
简要总结
Active parathyroid glands among renal dialysis patients contribute to calcified and hardened blood vessels. Such damage to the blood vessels, in turn, takes a significant toll in terms of cardiovascular disease. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. The investigators designed an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.
详细描述
Mineral metabolism disturbance and hyperparathyroidism contribute to arterial stiffness and vascular calcification. The vascular damage, in turn, contributes to significant cardiovascular morbidity and mortality of end-stage renal disease patients. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. We design an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •plasma parathyroid hormone level of at least 300 pg/ml (31.8 pmol/L)
- •aged 18 or older on peritoneal dialysis for at least three months
- •willingness to give written consent and comply with the study protocol
排除标准
- •evidence of cancer, active infection or diseases with limited life expectancy
- •diseases known to cause hypercalcaemia
- •adjusted serum calcium level below 2.1 mmol/L (8.4 mg/dL) after correction for albumin
- •participation in another interventional study within last 30 days of randomization
- •history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures
- •patients receiving drugs with a narrow therapeutic index and metabolized by cytochrome P-450 2D6 (which is inhibited by cinacalcet): flecainide, thioridazine and most tricyclic antidepressants
研究组 & 干预措施
Cinacalcet
Oral cinacalcet
干预措施: Cinacalcet (Drug)
结局指标
主要结局
Aortic pulse wave velocity after the cinacalcet treatment
时间窗: change in aortic pulse wave velocity at 52 weeks from baseline
as before
次要结局
- Change in calcium levels(within one year of treatment with cinacalcet)
- Aortic pulse wave velocity after the cinacalcet treatment(change in aortic pulse wave velocity at 26 weeks from baseline)
- Percent change in the values for parathyroid hormone levels(within one year of treatment with cinacalcet)
- Change in phosphorus levels(within one year of cinacalcet treatment)
- Change in calcium-phosphorus product(within one year of cinacalcet treatment)
研究者
Chow Kai Ming
Associate Consultant
Chinese University of Hong Kong