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临床试验/NCT03147573
NCT03147573已完成不适用

Validity of 1-hour Blood Pressure Monitoring Against the Usual Methods for Diagnosis of Hypertension

Consorci d'Atenció Primària de Salut de l'Eixample6 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年6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
入组人数
500
试验地点
6
主要终点
1-hour blood pressure monitoring

研究概览

简要总结

Blood pressure measurement methods and conditions are determinants of hypertension diagnosis. The classical methods such as office blood pressure measurement (OBPM) and home blood pressure monitoring (HBPM) have significant limitations. A recent British guideline recommends systematic 24-hour ambulatory blood pressure monitoring (ABPM). However, these devices are not available at all health centers and they can only be used by one patient per day. The aim this study is to validate a new method, 1-hour blood pressure monitoring (1BPM), to diagnose the hypertension.

Participants with suspected hypertension will be recruited from a population of patients seen at three primary health centers in an urban area. According to the sample size estimation, a minimum sample size of 214 participants would be needed for the study. Four diagnostic tests will be performed: OBPM at three visits, HBPM, AMPM and 1BPM. The test order for the 24-hour monitoring, and 1-hour monitoring, will be set randomly. Daytime records of ABPM will be compared to all other monitoring methods using the correlation coefficients and Bland Altman plots. The Kappa index will be used to calculate degree of agreement. The sensitivity and specificity of the methods will also be calculated.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • To visit routinely in the health centres where the study is carried out

排除标准

  • Severe physical or cognitive limitations
  • Atrial fibrillation or other heart rhythm disorders that could interfere with readings
  • Arm Circumference > 42cm
  • Arm with arteriovenous fistula
  • Mental disorders
  • Intolerance to the method of measurement
  • Hospitalization during the study period

结局指标

主要结局

1-hour blood pressure monitoring

时间窗: Assessed at 1 study visit (1 hour)

Blood pressure measurements obtained by 1-hour blood pressure monitoring

24-hour ambulatory blood pressure monitoring

时间窗: Assessed at 1 day

Blood pressure measurements obtained by 24-hour ambulatory blood pressure monitoring

Office blood pressure measurement

时间窗: Assessed at 3 study visits in two weeks

Blood pressure measurements obtained by office blood pressure measurement

Home blood pressure monitoring

时间窗: Assessed twice daily, ideally in the morning and evening, during at least four consecutive days, ideally seven

Blood pressure measurements obtained by home blood pressure monitoring

次要结局

未报告次要终点

研究者

发起方
Consorci d'Atenció Primària de Salut de l'Eixample
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Antoni Siso Almirall

Head of Research

Consorci d'Atenció Primària de Salut de l'Eixample

研究点 (6)

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