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临床试验/NCT05040516
NCT05040516Unknown不适用

The Role of Selenoprotein Activity and Blood Renalase Level in the Pathogenesis of Hypertension and Obstructive Sleep Apnea

Wroclaw Medical University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年1月27日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Assesment of blood renalase level

研究概览

简要总结

The aim of the study is to determine whether selenoprotein activity and blood renalase level correlate with subclinical hypertensive heart disease and obstructive sleep apnea. The correlation will be assessed using selected electrocardiographic, ultrasound and laboratory indicators.

详细描述

The study will be conducted in the Department and Clinic of Internal Medicine, Occupational Diseases, Hypertension and Clinical Oncology at Borowska 213 street in Wroclaw. This decision follows the high percentage of people with obstructive sleep apnea and hypertension among those hospitalized in the Clinic and also the wide availability of research tools in the hospital.

150 more patients with hypertension and obstructive sleep apnea will be included in the planned observational study.

The study is observational, research procedures are non-invasive and no additional medical experiment is planned. The study was approved by the Bioethics Committee of the Wroclaw Medical University.

Patients enrolled in the study will be asked to share the results of their previously performed examinations or, in case they do not have any, new examinations will be performed to complement the diagnostic process of hypertension and obstructive sleep apnea.

The planned procedures include: medical interview, physical examination with basic anthropometric measurements (age, height, body weight); biochemical tests including blood selenium, selenoproteins, renalase and creatinine levels; total antioxidant status (TAS), 24-hour Holter electrocardiography, polysomnography, ultrasound assessment of peripheral vascular endothelial function and echocardiography.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • arterial hypertension

排除标准

  • pregnancy
  • refusal to participate in the study

结局指标

主要结局

Assesment of blood renalase level

时间窗: One day

The Enzyme-linked immunosorbent assay (ELISA) to know blood renalase level

Assesment of the severity of obstructive sleep apnea

时间窗: One day

Full polysomnography

Assessment of arrhythmias

时间窗: One day

24-hour Holter ECG monitoring

Assessment of arrhythmias and cardiac morphology

时间窗: One day

Echocardiography

Assesment of blood selenoprotein P level

时间窗: One day

The Enzyme-linked immunosorbent assay (ELISA) to know blood selenoprotein P level

次要结局

  • Assesment of Blood Total Antioxidant Status (TAS)(One day)

研究者

发起方
Wroclaw Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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