Comparison of Medical Therapy (Oral Cinacalcet) Versus Surgical Therapy (Total Parathyroidectomy) on Vascular/Valvular Calcification in Chronic Peritoneal Dialysis Patients With Secondary Hyperparathyroidism - A Pilot Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Change in coronary artery calcium score
研究概览
简要总结
This is a pilot, prospective randomized controlled study with the primary objective to evaluate and compare medical treatment of severe SHPT, namely oral cinacalcet versus surgical treatment, that is, parathyroidectomy with forearm autografting, on the progression of coronary artery and valvular calcification and left ventricular mass index in endstage renal disease patients receiving peritoneal dialysis over 12 months. The change in arterial stiffening, left ventricular volume, aortic valve calcium score and bone mineral density, nutritional status and biochemical parameters, quality of life measures will be evaluated as secondary objectives of this study.
详细描述
Patients with severe secondary hyperparathyroidism (SHPT) are frequently complicated with vascular calcification. There is some suggestion that subtotal parathyroidectomy may reduce or stabilize vascular calcium scores in dialysis patients. Experimental data suggests that SHPT plays an important role in mediating uraemic arterial disease and that parathyroidectomy largely prevented the development of calcification. Cinacalcet has emerged as a novel therapy for the treatment of SHPT and has been shown to reduce the need for surgical parathyroidectomy. However, their effects on vascular, cardiac, bone and nutrition status have not been evaluated and compared with parathyroidectomy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ESRD patients on long-term peritoneal dialysis treatment, with elevated intact parathyroid hormone (iPTH) levels > 800pg/mL.
- •Patients with parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan.
- •Patients with age between 18 - 75 years.
排除标准
- •Patients with 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 underlying malignancy
- •Patients with hepatic dysfunction
研究组 & 干预措施
Cinacalcet treatment
Oral Cinacalcet treatment arm, 25mg daily to be administered and gradually step up as required to control iPTH between 2 - 9 times lab reference range, Maximum dose to be given is 100mg daily
干预措施: Cinacalcet (Drug)
Surgical total parathyroidectomy
Surgical total parathyroidectomy with forearm autografting will be performed for patients randomized to this arm.
干预措施: Surgical total parathyroidectomy with forearm autografting (Procedure)
结局指标
主要结局
Change in coronary artery calcium score
时间窗: 52 weeks
Change in coronary artery calcium score
change in left ventricular mass index
时间窗: 52 weeks
change in left ventricular mass index
次要结局
- change in left ventricular volume and ejection fraction(52 weeks)
- Change in aortic pulse wave velocity(24 and 52 weeks)
- change in intact parathyroid hormone (iPTH) level(52 weeks)
- change in handgrip strength(24 and 52 weeks)
- Change in subjective global assessment(24 and 52 weeks)
- Change in serum calcium and phosphorus(over 52 weeks)
- Change in aortic valve and mitral valve calcium score(52 weeks)
- change in augmentation index and heart rate adjusted augmentation index(over 52 weeks)
- change in bone mineral density at forearm, spine and femur(52 weeks)
- Quality of Life (QOL) scores(52 weeks)
- change in resting energy expenditure(24 and 52 weeks)
- change in lean muscle mass(52 weeks)
- Change in alkaline phosphatase(over 52 weeks)
- change in serum albumin(over 52 weeks)
- change in lymphocyte count(over 52 weeks)
- change in lipid profile(over 52 weeks)
- change in systolic and diastolic blood pressure(over 52 weeks)
- change in subendocardial viability ratio(over 52 weeks)
研究者
Dr. Angela Yee-Moon Wang
Honorary Associate Professor
The University of Hong Kong