Korean Registry of Target Organ Damages in Hypertension

NCT ID: NCT01861080

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2021-12-31

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

Conditions

Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

incident hypertensives

Inclusion Criteria:

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• participated in other clinical trials

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dongtan Sacred Heart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Suk Won Choi

Kyu-Hyung Ryu, M.D., Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyu-Hyung Ryu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dongtan Sacred Heart Hospital, Hallym University

Locations

Hallym University Dongtan Sacred Heart Hospital,

Hwaseong, Gyeonggido, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 28794898 (View on PubMed)

Other Identifiers

2012-005

Identifier Type: -

Identifier Source: org_study_id