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临床试验/NCT00710788
NCT00710788已完成不适用

Interventional, Multicenter, Prospective, Randomized Trial to Slow Down the Progression of Cardiovascular Calcifications to Reduce QTd in Incident Dialysis Patients

Azienda Sanitaria ASL Avellino 21 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
360
试验地点
1
主要终点
death due to cardiac arrhythmias or as sudden cardiac death defined as any deaths coded as "cardiac arrest, cause unknown" or "cardiac arrhythmia" without any exclusions

研究概览

简要总结

Research proposal to evaluate the impact of different phosphate binders on the progression of cardiovascular calcification and QT dispersion in new haemodialysis patients.

详细描述

The risk of developing cardiovascular diseases in patients on hemodialysis is higher than in general population. Higher levels of serum phosphate are associated with adverse cardiovascular outcomes, especially in the setting of overt hyperphosphatemia. Given the biological importance of serum phosphorus, it is conceivable that also within the normal range values the higher serum phosphate levels may be associated with the worst outcome. Several paper have shown that vascular calcifications in dialysis patients are associated with increased relative risk of death; it has also been demonstrated in uremic patients that vascular calcifications decrease arterial elasticity. We previously observed that vascular calcification directly correlate with QT interval (QTc) as well as QT dispersion (QTd) in dialysis. Also, QT correction (obtained by the correction of phosphoremia and dyslipidemia) can ameliorate the development of arrhythmia and sudden death. Aim of this study is to evaluate the relationship between vascular calcifications and both QTd increase and mortality in incident hemodialysis patients, and to investigate the efficacy of sevelamer to reduce vascular calcifications and QTd.

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
None

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

入选标准

  • incident patients on haemodialysis (CKD stage 5);
  • an informed consent will be provided at the study entry.

排除标准

  • congenital prolongation of QT segment syndrome;
  • QTc >440 ms; increased QTd;
  • bradycardia <50 bpm;
  • sintomatic arrhythmia or any other significant heart problems;
  • electrolyte unbalances (especially hypokalemia, hypomagnesemia, hypocalcemia);
  • abnormal liver function tests;
  • hypothyroidism.

研究组 & 干预措施

1

Experimental

sevelamer as Phosphate-binder treatment

干预措施: sevelamer phosphate-binders (Drug)

2

Active Comparator

Calcium carbonate

干预措施: Calcium Carbonate (Drug)

结局指标

主要结局

death due to cardiac arrhythmias or as sudden cardiac death defined as any deaths coded as "cardiac arrest, cause unknown" or "cardiac arrhythmia" without any exclusions

时间窗: 2 years

次要结局

  • QT interval; PWV; mortality for acute myocardial infarction, cerebral vascular accident and heart failure; Non-CV mortality(2 years)

研究者

发起方
Azienda Sanitaria ASL Avellino 2
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Biagio Di Iorio

MD, PhD

Azienda Sanitaria ASL Avellino 2

研究点 (1)

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