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Observational Study to Investigate Resistant Hypertension Prevalence in Korean General Hospitals (Teveten_RH)

2015年1月14日 更新者:Handok Inc.

Observational Study to Investigate Resistant Hypertension Prevalence Among the Hypertensive Patients Who Have Been Treated in Korean General Hospitals

Study Objectives The study is to identify prevalence, demography and clinical characteristics of patients with resistant hypertension among hypertensive patients who have been treated in general hospitals in Korea from Jan 2012 to Jun 2012.

  • Diagnosis of resistant hypertension: In case of clinic blood pressure exceeding the boundary of systolic blood pressure at 140mmHg and diastolic blood pressure at 90mmHg (hereinafter refer to as 140/90mmHg) (130/80mmHg for patients with diabetes mellitus or chronic renal disease) despite triple antihypertensive therapy at optimal dose may be diagnosed as resistant hypertension. Antihypertensive medications used include diuretics. Resistant hypertension may also be diagnosed when clinic blood pressure has reached the target value but quadruple or more of antihypertensives are used.
  • Diagnosis of controlled hypertension: Patients whose clinic blood pressure equals to 140/90mmHg (130/80mmHg for patients with diabetes mellitus or chronic renal disease) or less with the administration of antihypertensives at optimal dose may be diagnosed as controlled hypertension.

研究概览

地位

完全的

条件

详细说明

Primary Objective:

Prevalence in patients with resistant hypertension among hypertensive patients who have been treated in Korean general hospitals

Secondary Objectives:

Analysis of correlation in patients with resistant hypertension and patients with controlled hypertension who received triple antihypertensive therapy in terms of demography, clinical characteristics and other factors

  1. Demographic data (age, sex, and body mass index)
  2. Clinical characteristics

    • Vital signs
    • Lifestyles (history of drinking, smoking, and exercise)
    • Family history (hypertension, diabetes mellitus, dyslipidemia, cardiovascular disease, renal/adrenal disease, cerebrovascular disease, and respiratory disease)
    • Concurrent diseases (diabetes mellitus, dyslipidemia, cardiovascular disease, renal/adrenal disease, cerebrovascular disease, respiratory disease, and others)
    • History of antihypertensive therapy (past and present)
    • Medication compliance of antihypertensives
    • Concomitant medications

研究类型

观察性的

注册 (实际的)

1579

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Bundang-gu
      • Seongnam-si、Bundang-gu、大韩民国、463-717
        • Seoul National University Bundang Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

General hospitals

描述

Inclusion Criteria:

  1. Patients diagnosed of hypertension and in 20 years of age or older at the time of participating the study
  2. Patients visiting the medical institution during the period of 01 2012 ~ 06 2012 and who have received triple or more of antihypertensive therapy including diuretics (all different classes one another) at the time of the investigation.
  3. Patients who signed the informed consent form for data use before undergoing the study procedures.
  4. Patients who have capability and are willing to understand and fill in the questionnaire used in this study or who have a representative to fill in the questionnaire in case of lacking the capability.

Exclusion Criteria:

1. Patients who fail to meet the inclusion criteria.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 时间观点:横截面

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Prevalence of resistant hypertension
大体时间:up to 6 months
Prevalence of resistant hypertension will be estimated, and its 95% confidence interval will be calculated. In addition, proportion of controlled hypertensive patients and its 95% confidence interval will be calculated.
up to 6 months

次要结果测量

结果测量
措施说明
大体时间
Analysis of correlation in patients with resistant hypertension and patients with controlled hypertension who received triple antihypertensive therapy in terms of demography, clinical characteristics and other factors
大体时间:up to 6 months
Clinical characteristics in subjects diagnosed of resistant hypertension and those diagnosed of controlled hypertension will be described in summary.
up to 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Dong-ju Choi, MD、Seoul National University Bundang Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年2月1日

初级完成 (实际的)

2014年7月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2012年12月17日

首先提交符合 QC 标准的

2012年12月19日

首次发布 (估计)

2012年12月20日

研究记录更新

最后更新发布 (估计)

2015年1月15日

上次提交的符合 QC 标准的更新

2015年1月14日

最后验证

2014年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • HD_EPR_OS2012

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