Korean Registry of Target Organ Damages in Hypertension

Study Overview
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Brief Summary
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The objective of this study is to know prevalence of clinical or subclinical target organ damages in Korea hypertensives by constructing nationwide hypertension registry. We will register 5000 consecutive patients with incident hypertension at 20 major university hospitals in South Korea. We will investigate clinical/subclinical target organ damages, renin/aldosterone level and cardiovascular events in each patient.

Detailed Description
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Background: the exact prevalence of target organ damages in Korean hypertensives are unknown. Study Objective: to investigate the prevalence of target organ damages in Korean patients with incident hypertension. Study Design: prospective, multi-center and observational study Study Populaton: approximately 5000 consecutive patients with incident hypertension, who visited outpatients clinics and agreed to participate in the registry Primary outcome Subclinical organ damages left ventricular hypertrophy on electrocardiogram or echocardiography increased intima media thickness of carotid artery (> 0.9 mm) or plaque increased pulse wave velocity (> 12 m/s) low estimated glomerular filtration rate (< 60 ml/min/1.73 m2) or creatinine clearance (<60 ml/min) Established CV or renal disease cerebrovascular disease: ischemic stroke; cerebral stroke; transient ischemic attack Heart disease: myocardial infarction; angina; coronary revascularization; heart failure Renal disease: diabetic retinopathy; serum creatinine M > 133, W > 124 mmol/L; proteinuria > 300 mg/24 hr Peripheral artery disease Advanced retinopathy: hemorrhage or exudates, papilledema

Official Title
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Observational Study of Clinical Characteristics and Prognostic Factors of Korean Hypertensives

Conditions
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Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age≧30years primary incident hypertension singed informed consent Exclusion Criteria: participated in other clinical trials

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| incident hypertensives<br>Inclusion Criteria: age≧30years primary incident hypertension signed informed consent | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular hypertrophy | left ventricular hypertrophy on electrocardiogram or echocardiography Sokolow-Lyon > 38 mm; left ventricular mass index male >= 125 g/m2, female >=110 g/m2) | at enrollment | 
| Intima media thickness of carotid artery | increased intima media thickness of carotid artery (> 0.9 mm) or presence of plaque | at enrollment | 
| pulse wave velocity | increased pulse wave velocity (> 12 m/s) | at enrollment | 
| kidney function | low estimated glomerular filtration rate (< 60 ml/min/1.73 m2) or creatinine clearance (< 60 ml/min) | at enrollment | 
| cerebrovascular accident | ischemic stroke, cerebral hemorrhage, or transient ischemic attack confirmed by a neurologist | at enrollment | 
| renal disease | serum creatinine male > 1.5 mg/dl, female > 1.4 mg/dl; proteinuria > 300 mg/24hr | at enrollment | 
| peripheral artery disease | ankle to brachial blood pressure ratio < 0.9 | at enrollment | 
| retinopathy | retinal hemorrhage or exudate, papilledema confirmed by an ophthalmologist | at enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertension | high blood pressure confirmed by ambulatory blood pressure monitoring (24hr average systolic blood pressure >=135 mm Hg, diastolic blood pressure >= 85 mm Hg | at enrollment | 
| Dyslipidemia | total cholesterol 190 mg/dl or LDL > 115 mg/dl, HDL male < 40 mg/dl, female < 46 mg/dl or triglyceride > 150 mg/dl | at enrollment | 
| abnormal fasting plasma glucose | abnormal fasting plasma glucose (102-125 mg/dl) | at enrollment | 
| abdominal obesity | waist circumference male > 102 cm, female > 88 cm | at enrollment | 
| diabetes mellitus | fasting plasma glucose >= 126 mg/dl; postload plasma glucose > 198 mg/dl | at enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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target organ damage, incident hypertension, cohort