NCT00745719已完成不适用
A Pilot Study to Evaluate the Efficacy of Total Parathyroidectomy in Retarding Cardiovascular Calcification in End-stage Renal Disease Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Change in vascular and valvular calcium scores
研究概览
简要总结
To test the hypothesis that total parathyroidectomy retards cardiovascular calcification, improves bone mineral density, reduces cardiac hypertrophy and arterial stiffening in end-stage renal disease patients on maintenance dialysis.
详细描述
Secondary hyperparathyroidism (SHPT) in patients with end-stage renal disease contributes to increased cardiovascular morbidity and mortality via different mechanisms. Uncontrolled hyperparathyroidism is associated with left ventricular hypertrophy and has been implicated in the development of cardiac interstitial fibrosis and diastolic dysfunction.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Endstage renal disease patients receiving either long-term hemodialysis or peritoneal dialysis treatment, with elevated intact parathyroid hormone (iPTH) levels > 500pg/ml on two or more occasions.
- •Patients with parathyroid nodular or diffuse hyperplasia identified by ultrasound imaging or radioisotope scan.
- •Patients who provide informed consent for the study.
排除标准
- •Patients with significant background valvular heart disease
- •Patients who are unfit for general anaesthesia
- •Patients with acute myocardial infarction within recent two months
- •Patients with poor general condition
- •Patients with plans for living related kidney transplant within 1 year
- •Patients with previous history of parathyroidectomy
- •Patients with calciphylaxis
- •Patients with underlying active malignancy
- •Patients with contraindication for MRI
结局指标
主要结局
Change in vascular and valvular calcium scores
时间窗: 12 months
次要结局
- change in aortic pulse wave velocity,(12 months)
- changes in inflammatory marker(12 months)
- Change in bone mineral density(12 months)
- changes in quality of life scores(12 months)
- changes in subjective global assessment(6 and 12 months)
- changes in alkaline phosphatase(6 and 12 months)
- changes in handgrip strength(12 months)
- change in left ventricular mass, volume and function(12 months)
- changes in Serum calcium and phosphate(6 and 12 months)
- changes in HOMA index(6 and 12 months)
- changes in iPTH(6 and 12 months)
- changes in serum albumin(6 and 12 months)
研究者
Dr. Angela Yee-Moon Wang
Honorary Associate Professor
The University of Hong Kong
研究点 (2)
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