Observational Study to Investigate Resistant Hypertension Prevalence in Korean General Hospitals

NCT01753206 | Completed

• 1 other identifier: HD_EPR_OS2012
• Study Type: observational
• Target: 1,579
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  up to 6 months

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General hospitals

You may qualify if:

• Patients diagnosed of hypertension and in 20 years of age or older at the time of participating the study
• 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.
• Patients who signed the informed consent form for data use before undergoing the study procedures.
• 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.

Sponsors & Collaborators

• Handok Inc.: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Bundang-gu, 463-717, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dong-Ju Choi, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 20, 2012
• Study Start: February 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 15, 2015

Record last verified: 2014-01

Locations

KR (1)