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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 1579

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bundang-gu
    • Seongnam-si, Bundang-gu, Korea, Republic of, 463-717
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

General hospitals

Description

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.

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of resistant hypertension	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Clinical characteristics in subjects diagnosed of resistant hypertension and those diagnosed of controlled hypertension will be described in summary.	up to 6 months

Collaborators and Investigators

• Sponsor: Handok Inc.
• Investigators: Principal Investigator: Dong-ju Choi, MD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 19, 2012
• First Posted (Estimate): December 20, 2012

Study Record Updates

• Last Update Posted (Estimate): January 15, 2015
• Last Update Submitted That Met QC Criteria: January 14, 2015
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HD_EPR_OS2012