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临床试验/NCT05053685
NCT05053685已完成不适用

Utility of Plasma and Urine Metanephrines in the Diagnosis of Phaeochromocytoma in Patients With Obstructive Sleep Apnoea

Changi General Hospital1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2020年7月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
1
主要终点
Urine and plasma metanephrines

研究概览

简要总结

Although most patients have essential (unexplained) hypertension, some patients have a treatable underlying condition. One such condition is phaeochromocytoma, a tumour that produces excessive stress hormones. Left undiagnosed, patients may develop a hypertensive crisis that can be fatal. Measurements of stress hormones (both 24-hour urine collection and morning blood tests) are highly sensitive for detecting these tumours. However, these stress hormones may also be elevated in obstructive sleep apnoea (OSA) which affects 1 in 5 adults.

The investigators hypothesize that in patients with OSA, blood tests will be better than 24-hr urine tests at ruling out a tumour. If this is confirmed, then OSA patients with suspected phaeochromocytoma could be investigated with a morning blood test instead of a traditional urine test, reducing unnecessary additional tests and patient anxiety.

In this single site study, the investigators plan to recruit 70 patients undergoing polysomnography. 24hr urine and bloods will be measured. Patients with elevated hormone levels will undergo imaging to rule out a tumour.

The primary outcome will be the accuracy of each test in ruling out a tumour. The secondary outcomes will be the relationship between stress hormone level and severity of OSA, which may help to explain the increased cardiovascular risk in patients with OSA, and the change in stress hormone level with treatment for OSA

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 21-70 years attending for a sleep study to evaluate for OSA

排除标准

  • Medications that can cause changes in metanephrine levels
  • Other factors that can cause changes in metanephrine levels
  • Renal impairment (eGFR < 60ml/min)
  • Other serious medical conditions

结局指标

主要结局

Urine and plasma metanephrines

时间窗: 1 year

Measurement of plasma metanephrines

次要结局

  • Relationship between metanephrine level and severity of OSA(1 year)
  • Change in metanephrine levels with treatment for OSA(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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