Observational Study of Clinical Characteristics and Prognostic Factors of Korean Hypertensives
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Dongtan Sacred Heart Hospital
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- retinopathy
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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 1. left ventricular hypertrophy on electrocardiogram or echocardiography 2. increased intima media thickness of carotid artery (\> 0.9 mm) or plaque 3. increased pulse wave velocity (\> 12 m/s) 4. low estimated glomerular filtration rate (\< 60 ml/min/1.73 m2) or creatinine clearance (\<60 ml/min) * Established CV or renal disease 1. cerebrovascular disease: ischemic stroke; cerebral stroke; transient ischemic attack 2. Heart disease: myocardial infarction; angina; coronary revascularization; heart failure 3. Renal disease: diabetic retinopathy; serum creatinine M \> 133, W \> 124 mmol/L; proteinuria \> 300 mg/24 hr 4. Peripheral artery disease 5. Advanced retinopathy: hemorrhage or exudates, papilledema
Investigators
Suk Won Choi
Kyu-Hyung Ryu, M.D., Professor
Dongtan Sacred Heart Hospital
Eligibility Criteria
Inclusion Criteria
- •age≧30years
- •primary incident hypertension
- •singed informed consent
Exclusion Criteria
- •participated in other clinical trials
Outcomes
Primary Outcomes
retinopathy
Time Frame: at enrollment
retinal hemorrhage or exudate, papilledema confirmed by an ophthalmologist
pulse wave velocity
Time Frame: at enrollment
increased pulse wave velocity (\> 12 m/s)
left ventricular hypertrophy
Time Frame: at enrollment
left ventricular hypertrophy on electrocardiogram or echocardiography Sokolow-Lyon \> 38 mm; left ventricular mass index male \>= 125 g/m2, female \>=110 g/m2)
kidney function
Time Frame: at enrollment
low estimated glomerular filtration rate (\< 60 ml/min/1.73 m2) or creatinine clearance (\< 60 ml/min)
Intima media thickness of carotid artery
Time Frame: at enrollment
increased intima media thickness of carotid artery (\> 0.9 mm) or presence of plaque
peripheral artery disease
Time Frame: at enrollment
ankle to brachial blood pressure ratio \< 0.9
cerebrovascular accident
Time Frame: at enrollment
ischemic stroke, cerebral hemorrhage, or transient ischemic attack confirmed by a neurologist
renal disease
Time Frame: at enrollment
serum creatinine male \> 1.5 mg/dl, female \> 1.4 mg/dl; proteinuria \> 300 mg/24hr
Secondary Outcomes
- Hypertension(at enrollment)
- Dyslipidemia(at enrollment)
- abdominal obesity(at enrollment)
- abnormal fasting plasma glucose(at enrollment)
- diabetes mellitus(at enrollment)