Clinical trial NCT02024100: Observational Study to Investigate the Effectiveness of Eprosartan on Pulse Pressure (Teveten_MS)
Official title: Observational Study to Investigate the Effectiveness of Eprosartan on Pulse Pressure in Hypertensive Patients With Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-31
Enrollment: 109
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General hospitals

Brief summary: The study is to identify the effectiveness of Eprosartan on pulse pressure in hypertensive patients with metabolic syndrome

-Definition of pulse pressure (PP): Difference between systolic and diastolic blood pressure produced one heart beat.

Detailed description: Primary Objective

-To assess the changes of pulse pressure at 12 weeks

Secondary Objectives

* To assess the changes of pulse pressure at 4, 24 weeks
* To assess the changes of systolic blood pressure and diastolic blood pressure at each visit
* Percentage of responder rate\* at each visit and time to get normalized BP from enrollment
* Responder rate at last visit
* To assess IIEF-5 (5-item Version of the International Index of Erectile Function) score at enrollment and 24 weeks (percentage of patients with ED according to IIEF-5, Changes of IIEF-5 domains)
* Percentage of patients with erectile dysfunction (ED) according to IIEF-5 and changes of PP in subgroup (age 65, body mass index (BMI) 23, diabetes mellitus, dyslipidemia, benign prostate hypertrophy)
* Analysis of correlation between ED and concomitant disease and concomitant medications in patients who received Eprosartan
* Score changes of Framingham 10-year Coronary Heart Disease (CHD) risk at 1st visit, 4th visit
* Percentages of Eprosartan monotherapy and multiple antihypertensive therapies at enrollment and last visit
* Reason for treatment discontinuation (Inadequate BP control, adverse events, others)
* Adverse events

  * Responder rate: SBP \<140mmHg and DBP \<90mmHg (SBP \<140mmHg and DBP \<85mmHg for patients with diabetes mellitus)

Eligibility criteria: Inclusion Criteria:

1. 20-80 years old patient at the 1st visit
2. Patient who is determined to prescribe Eprosartan for hypertension (patient with at least one of the following conditions) (1) Newly diagnosed hypertension (2) Inability to tolerate hypertension (for example: adverse event) (3) Lack of response to current antihypertensive medications
3. Metabolic syndrome patient (fulfill 3 or more components before enrollment) (1) Waist circumference (\>90 for men, \>80 for women) (2) Triglycerides (≥150mg/dl) (3) HDL cholesterol (\<40mg/dl for men, \<50mg/dl for women) (4) SBP≥130mmHg or DBP≥85mmHg or on antihypertensive medications) (5) Fasting glucose level (≥100mg/dl) or on antidiabetic medications

   * MS diagnosis origin: Korean diabetes association

Exclusion Criteria:

1. Patients who is administered with 3 or more than 3 antihypertensive drugs
2. Patients who is contraindicated with Eprosartan by the product label

Primary outcomes:
measure: To assess the changes of pulse pressure at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: - changes of pulse pressure at 4, 24 weeks - changes of blood pressure at 4, 12, 24 weeks - Duration to get normalized BP - assess IIEF-5 score - Score changes of Framingham 10-year CHD risk
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Bundang-gu
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chang Hwan Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References: