Korean Registry of Target Organ Damages in Hypertension (KorHR)

Observational Study of Clinical Characteristics and Prognostic Factors of Korean Hypertensives

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension

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

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggido
    • Hwaseong, Gyeonggido, Korea, Republic of, 445-170
      • Hallym University Dongtan Sacred Heart Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Korean patients with incident hypertensive, who visited university hospital

Description

Inclusion Criteria:

• age≧30years
• primary incident hypertension
• singed informed consent

Exclusion Criteria:

• participated in other clinical trials

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
incident hypertensives; Inclusion Criteria: age≧30years; primary incident hypertension; signed informed consent

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
major cardiovascular events	death, stroke, myocardial infarction and heart failure(confirmed by a cardiologist)	after follow-up period of 36 months

Collaborators and Investigators

• Sponsor: Dongtan Sacred Heart Hospital
• Investigators: Principal Investigator: Kyu-Hyung Ryu, MD, PhD, Dongtan Sacred Heart Hospital, Hallym University

Publications and helpful links

General Publications

• Choi SW, Han SW, Ok JS, Yoo BS, Shin MS, Park SH, Ryu KH. A multicenter cohort study of primary hypertension in Korea: study design and interim analysis of the Korean registry of target organ damage in hypertension (KorHR). Clin Hypertens. 2017 Aug 2;23:16. doi: 10.1186/s40885-017-0072-2. eCollection 2017.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 16, 2013
• First Submitted That Met QC Criteria: May 21, 2013
• First Posted (Estimate): May 23, 2013

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: cohort; target organ damage; incident hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2012-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED