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临床试验/NCT05640128
NCT05640128已完成不适用

Determination of Threshold Values of Aldosterone in HPLC-MS/MS, of Renin and of the Aldosterone / Renin Ratio for the Diagnosis of Primary Hyperaldosteronism

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2018年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
1
主要终点
Aldosterone values in LC-MS/MS (and renin) and RAR calculation and calculation of an RAR threshold for PAH screening which differentiates between essential hypertension and PAH.

研究概览

简要总结

collaborative work within 2 hospitals at the CHU of Caen, at the CHRU of Lille, concerning the evaluation of the biological markers of primary hyperaldosteronism (PAH) with the dosage of aldosterone in LC -MS/MS, which is performed in both centers, with two different techniques. The main objective is to define the range of Aldosterone concentrations in LC MS/MS, of renin in an automated method, in populations of healthy volunteers, essential hypertensives, and hypertensives with primary hyperaldosteronism. , in order to establish a threshold for the screening of PAH by the RAR, and for the confirmation of PAH by a dynamic test with an Aldosterone threshold post salt load test.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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
否

入选标准

  • •Patients (18-75 years old) with moderate to severe hypertension, which justifies carrying out an etiological assessment in a hospital environment.
  • •Assessment carried out in compliance with the standardized measurement conditions of the RAR defined by the SFE consensus,
  • •Signature of a written consent by the patient

排除标准

  • •Patient on antihypertensive treatment other than alpha-blockers, calcium channel blockers or centrally acting antihypertensive
  • •Etiology of secondary hypertension other than PAH

研究组 & 干预措施

Aldosterone in HPLC-MS/MS,

Other

Aldosterone in HPLC-MS/MS measurement

干预措施: Aldosterone in HPLC-MS/MS (Other)

结局指标

主要结局

Aldosterone values in LC-MS/MS (and renin) and RAR calculation and calculation of an RAR threshold for PAH screening which differentiates between essential hypertension and PAH.

时间窗: baseline

Define the range of concentrations of Aldosterone in LC MS/MS, of renin in an automated immunological method with calculation of the RAR, in populations of healthy volunteers, essential hypertensives, and hypertensives with primary hyperaldosteronism , in order to establish a threshold for the detection of PAH by the RAR, and for the confirmation of PAH by a dynamic test of confirmation by Aldosterone.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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