Korean Registry of Target Organ Damages in Hypertension

Hypertension Clinical Trial

— KorHR  

Official title:

Observational Study of Clinical Characteristics and Prognostic Factors of Korean Hypertensives

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01861080
• Other study ID #: 2012-005
• Status: Active, not recruiting
• Start date: May 2013
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2019
• Source: Dongtan Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• age?30years

• primary incident hypertension

• singed informed consent

Exclusion Criteria:

• participated in other clinical trials

Related Conditions & MeSH terms

• Hypertension

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital,	Hwaseong	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
Dongtan Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	major cardiovascular events	death, stroke, myocardial infarction and heart failure(confirmed by a cardiologist)	after follow-up period of 36 months
Primary	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
Primary	Intima media thickness of carotid artery	increased intima media thickness of carotid artery (> 0.9 mm) or presence of plaque	at enrollment
Primary	pulse wave velocity	increased pulse wave velocity (> 12 m/s)	at enrollment
Primary	kidney function	low estimated glomerular filtration rate (< 60 ml/min/1.73 m2) or creatinine clearance (< 60 ml/min)	at enrollment
Primary	cerebrovascular accident	ischemic stroke, cerebral hemorrhage, or transient ischemic attack confirmed by a neurologist	at enrollment
Primary	renal disease	serum creatinine male > 1.5 mg/dl, female > 1.4 mg/dl; proteinuria > 300 mg/24hr	at enrollment
Primary	peripheral artery disease	ankle to brachial blood pressure ratio < 0.9	at enrollment
Primary	retinopathy	retinal hemorrhage or exudate, papilledema confirmed by an ophthalmologist	at enrollment
Secondary	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
Secondary	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
Secondary	abnormal fasting plasma glucose	abnormal fasting plasma glucose (102-125 mg/dl)	at enrollment
Secondary	abdominal obesity	waist circumference male > 102 cm, female > 88 cm	at enrollment
Secondary	diabetes mellitus	fasting plasma glucose >= 126 mg/dl; postload plasma glucose > 198 mg/dl	at enrollment