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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Handok Pharmaceuticals Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01753206
First received: December 17, 2012
Last updated: January 24, 2014
Last verified: January 2014

December 17, 2012
January 24, 2014
February 2013
December 2014   (final data collection date for primary outcome measure)
Prevalence of resistant hypertension [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
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.
Prevalence of resistant hypertension [ Time Frame: from Jan 2012 to Jun 2012 ] [ Designated as safety issue: No ]

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. For this, through chart review investigated by each center, prevalence of resistant hypertension will be estimated from the proportion of patients whose blood pressure exceeds the boundary* mentioned above among those receiving triple antihypertensive therapy or patients receiving quadruple or more of antihypertensive therapy regardless of blood pressure, among the entire hypertensive patients. Likewise, the proportion of controlled hypertensive patients will be estimated from the proportion of patients receiving triple antihypertensive therapy with their blood pressure at the boundary* or lower that was mentioned above.

*140/90mmHg (130/80mmHg for patients with diabetes mellitus or chronic renal disease)

Complete list of historical versions of study NCT01753206 on ClinicalTrials.gov Archive Site
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 [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
Clinical characteristics in subjects diagnosed of resistant hypertension and those diagnosed of controlled hypertension will be described in summary.
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 [ Time Frame: from Jan 2012 to Jun 2012 ] [ Designated as safety issue: No ]

Clinical characteristics in subjects diagnosed of resistant hypertension and those diagnosed of controlled hypertension will be described in summary.

For this, various demographic characteristics and clinical characteristics will be presented in summary statistics by subject group of the two above. If demographic and clinical characteristics are continuous data, they will be summarized in descriptive statistic; if categorical data, they will be presented in frequency and percentage. If necessary, T-test or Chi-square test will be done to test whether there is a significant difference in characteristics between two subject groups by item.

Additionally if there is a significant item in single variate analysis, logistic regression analysis will be performed by having the presence of resistant hypertension as a dependent variable, seeking the significantly influencing factors (items).

Not Provided
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Observational Study to Investigate Resistant Hypertension Prevalence in Korean General Hospitals
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.

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
Observational
Time Perspective: Cross-Sectional
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Non-Probability Sample

General hospitals

Hypertension
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1800
December 2014
December 2014   (final data collection date for primary outcome measure)

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.

Both
20 Years and older
No
Contact: Dongjin Shin 82-2-527-5383 dongjin.shin@handok.com
Korea, Republic of
 
NCT01753206
HD_EPR_OS2012
No
Handok Pharmaceuticals Co., Ltd.
Handok Pharmaceuticals Co., Ltd.
Not Provided
Principal Investigator: Dong-Ju Choi, MD Seoul National University Bundang Hospital
Handok Pharmaceuticals Co., Ltd.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP