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临床试验/NCT03937349
NCT03937349已完成不适用

Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients: a Prospective Cohort Study

Saint Petersburg State University, Russia1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2019年5月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
Change in coronary artery calcium score measured with CT

研究概览

简要总结

This is a prospective cohort study aimed to evaluate change of cardiovascular calcification after parathyroidectomy in patients with end-stage renal disease on dialysis compared with control group on conservative treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age > 18 years
  • ESRD patients receiving long-term hemodialysis or peritoneal dialysis treatment
  • Severe secondary hyperparathyroidism defined as iPTH level > 800 pg/ml, followed with hypercalcemia and/or hyperphosphatemia; with presence of one or more nodular or diffuse parathyroid hyperplasia confirmed with CT

排除标准

  • Primary hyperparathyroidosis as a cause of ESRD

结局指标

主要结局

Change in coronary artery calcium score measured with CT

时间窗: 18 months

Change in vascular calcification score measured with semi-quantitative (Kauppila) test

时间窗: 18 months

次要结局

  • Change in serum phosphate level(18weeks)
  • Change in alkaline phosphatase(18 months)
  • Change in intact parathyroid hormone (iPTH) level(18 months)
  • Change in serum calcium level(18 months)
  • Change in heart valve calcium score(18 months)
  • Serious adverse events (cardiovascular events, death, fractures, emergency hospital admissions) during the follow-up period(18 months)

研究者

发起方
Saint Petersburg State University, Russia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ekaterina Parshina

Principal investigator

Saint Petersburg State University, Russia

研究点 (1)

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