Korean Registry of Target Organ Damages in Hypertension
- Conditions
- Hypertension
- Registration Number
- NCT01861080
- Lead Sponsor
- Dongtan Sacred Heart Hospital
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3000
- age≧30years
- primary incident hypertension
- singed informed consent
- participated in other clinical trials
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intima media thickness of carotid artery at enrollment increased intima media thickness of carotid artery (\> 0.9 mm) or presence of plaque
retinopathy at enrollment retinal hemorrhage or exudate, papilledema confirmed by an ophthalmologist
pulse wave velocity at enrollment increased pulse wave velocity (\> 12 m/s)
left ventricular hypertrophy 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 at enrollment low estimated glomerular filtration rate (\< 60 ml/min/1.73 m2) or creatinine clearance (\< 60 ml/min)
peripheral artery disease at enrollment ankle to brachial blood pressure ratio \< 0.9
cerebrovascular accident at enrollment ischemic stroke, cerebral hemorrhage, or transient ischemic attack confirmed by a neurologist
renal disease at enrollment serum creatinine male \> 1.5 mg/dl, female \> 1.4 mg/dl; proteinuria \> 300 mg/24hr
- Secondary Outcome Measures
Name Time Method Hypertension at enrollment high blood pressure confirmed by ambulatory blood pressure monitoring (24hr average systolic blood pressure \>=135 mm Hg, diastolic blood pressure \>= 85 mm Hg
Dyslipidemia at enrollment total cholesterol 190 mg/dl or LDL \> 115 mg/dl, HDL male \< 40 mg/dl, female \< 46 mg/dl or triglyceride \> 150 mg/dl
abdominal obesity at enrollment waist circumference male \> 102 cm, female \> 88 cm
abnormal fasting plasma glucose at enrollment abnormal fasting plasma glucose (102-125 mg/dl)
diabetes mellitus at enrollment fasting plasma glucose \>= 126 mg/dl; postload plasma glucose \> 198 mg/dl
Trial Locations
- Locations (1)
Hallym University Dongtan Sacred Heart Hospital,
🇰🇷Hwaseong, Gyeonggido, Korea, Republic of