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临床试验/NCT06236698
NCT06236698已完成不适用

Accuracy of 24-hour Urinary Aldosterone Testing in Diagnosing Primary Aldosteronism and Analysis of Drug Interference Factors

Zhiming Zhu1 个研究点 分布在 1 个国家目标入组 999 人开始时间: 2022年3月1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
Zhiming Zhu
入组人数
999
试验地点
1
主要终点
The cut-off value of 24-hour urinary aldosterone for distinguishing primary aldosteronism from primary hypertension.

研究概览

简要总结

This is an observational study to define the cut-off value of 24-hour urinary aldosterone for diagnosing primary aldosteronism in hypertensive patients in our center. Plasma aldosterone and renin measurements are subject to significant intra-individual variability, including variation related to posture, time of day and sodium balance. Aldosterone secretion is not constant and may be subject to diurnal variation. As such one-off testing of ARR, does not consider the salt status of the individual necessitating repetition of tests to ensure false negative or false positive test results are ruled out. The value of accumulated aldosterone in a 24-hour sample has the advantage that it does not depend on circadian variation. This study will help establish the positivity rates of 24-hour urine aldosterone, and test the robustness of current standard guidelines for primary aldosteronism screening and case confirmation.

Previous studies reported that primary aldosteronism is associated with a higher risk of CV complications and a higher prevalence of target organ damage. Also, previous studies reported on the association of echocardiographic parameters with circulating or urinary aldosterone. Therefore, we intent to investigate the independent associations of different target organ damage with the urinary excretion of aldosterone.

研究设计

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

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

入选标准

  • Aged 18 years and above.
  • Meets the 2018 Chinese guidelines for prevention and treatment of hypertension for a diagnosis of hypertension with an age of onset of hypertension between 18-80 years.
  • Meets the Endocrine Society Clinical Practice Guidelines for a diagnosis of primary aldosteronism with an age of onset of hypertension between 18-80 years.

排除标准

  • Other causes of secondary hypertension, including renal hypertension, renovascular hypertension and adrenal hypertension (i.e., pheochromocytoma and Cushing syndrome).
  • Urine output less than 400ml per day.
  • Severe renal insufficiency with a glomerular filtration rate < 60 mL/min/1.73 m
  • lack of 24-h urinary aldosterone data.

结局指标

主要结局

The cut-off value of 24-hour urinary aldosterone for distinguishing primary aldosteronism from primary hypertension.

时间窗: 2 years

This study will define the cut-off value of 24-hour urinary aldosterone for identifying patients with primary aldosteronism in hypertensive patients.

次要结局

  • Impacts of antihypertensive medications on 24-h urinary aldosterone levels(2 years)
  • The relationship between 24-hour urinary aldosterone and target organ damage in hypertension.(2 years)

研究者

发起方
Zhiming Zhu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhiming Zhu

Professor

Third Military Medical University

研究点 (1)

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