跳至主要内容
临床试验/NCT05765786
NCT05765786招募中不适用

Do we Miss a Common Subset of Primary Aldosteronism in Which There is Cyclical or Exaggerated Diurnal Variation in Secretion?

Queen Mary University of London1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Sensitivity and specificity of 24 hour urine tetrahydroaldosterone excretion.

研究概览

简要总结

The goal of this observational study is to see if there is a cyclical or exaggerated diurnal variation in aldosterone production in people with Primary Aldosteronism.

详细描述

The main questions it aims to answer are:

  • Can we diagnose more people if we used 24 hour urine measurements?
  • In those with high amounts of aldosterone in their urine, is there a variable pattern to their aldosterone production?

Participants will have a 24 hour urine measurement. They will also have multiple blood tests throughout the day to study the variability in aldosterone secretion.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People with clinically suspected PA but have not met criteria for diagnosis. Suspicion based on low-renin (renin activity <0.5 nmol/h/L or renin mass <5 ng/L), plasma sodium > 140mmol/L or plasma potassium < 4mmol/L.
  • Patients who have been diagnosed with PA and had previous aldosterone samples <277 pmol/L, a level which would normally not qualify for confirmatory testing.
  • Patients with aldosterone results done at different times that indicate variability in production.
  • Willing to consent and participate in the study.

排除标准

  • Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks.
  • People on end of life treatment.

结局指标

主要结局

Sensitivity and specificity of 24 hour urine tetrahydroaldosterone excretion.

时间窗: 12 months

Can measurement of 24 hour urine tetrahydroaldosterone excretion detect more people with PA than current conventional screening tests?

次要结局

  • Differences in timed day and night urine THA measurements.(12 months)
  • Variation in aldosterone secretion from day series in those with positive 24h urine THA and those with negative 24h urine THA.(12 months)
  • Complete biochemical cure of PA in this cohort of patients that qualify for adrenalectomy.(12 months)
  • Complete or partial clinical cure rate of this cohort of patients that qualify for adrenalectomy(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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