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临床试验/NCT03855605
NCT03855605已完成不适用

Evaluation of Algorithm for Diagnosis of Hypertension by Home Blood Pressure Monitoring

DongGuk University1 个研究点 分布在 1 个国家目标入组 470 人开始时间: 2015年11月17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
470
试验地点
1
主要终点
validation of the diagnostic algorithm of hypertension

研究概览

简要总结

Home blood pressure measurement has been recommended to use in the diagnosis of hypertension. The investigators have developed diagnostic algorithm of hypertension by using 24-hour and home blood pressure measurement. However, the diagnostic agreement between home blood pressure measurement and 24-hour ambulatory blood pressure measurement is about 70 - 85%. The discrepancy of diagnosis between home blood pressure measurement and 24-hour ambulatory blood pressure is one of the barriers to introduce home blood pressure measurement in the diagnosis of hypertension.

To solve the discrepancy, identifying the characteristic patients showing discrepancy of hypertension diagnosis between home blood pressure measurement and 24-hour ambulatory blood pressure measurement is needed.

The purpose of the present study are (1) to validate the diagnostic algorithm of hypertension by using 24-hour ambulatory blood pressure and home blood pressure measurement the investigators have developed, and (2) to identifying the characteristics of patients showing discrepancy of diagnosis between 24-hour ambulatory blood pressure and home blood pressure measurement, and (3) lastly to improve the diagnostic algorithm of hypertension by using home blood pressure measurement.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Men and women
  • •Patients with high blood pressure measured by doctors at the outpatient office

排除标准

  • •Patients taking antihypertensive drugs or blood pressure affecting drugs within 1 month
  • •Secondary hypertension
  • •Hypertensive emergency and urgency
  • •Severe heart failure (NYHA III and IV)
  • •Angina with 6 months
  • •Myocardial infarction within 6 months
  • •Peripheral artery disease within 6 months
  • •Significant arrhythmia (i.e. ventricular tachycardia and fibrillation, atrial fibrillation, atrial flutter)
  • •Pregnancy
  • •Night labor, shift worker
  • •Those who are currently participating in other clinical studies
  • •Those who have taken other clinical trial drugs within the past month
  • •According to the opinion of the researcher, those who have or may have a disease that may interfere with the completion of the study
  • •History of drug or alcohol dependence within 6 months

结局指标

主要结局

validation of the diagnostic algorithm of hypertension

时间窗: at baseline

validation of the diagnostic algorithm of hypertension by using 24-hour ambulatory blood pressure and home blood pressure measurement

次要结局

  • the characteristics of patients showing discrepancy of diagnosis(at baseline)
  • the change of diagnostic discrepancy(from baseline to more than 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Moo-Yong Rhee

Professor, Principal Investigator

DongGuk University

研究点 (1)

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