NCT01861080

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

8.7 years

First QC Date

May 16, 2013

Last Update Submit

February 6, 2019

Conditions

Keywords

target organ damageincident hypertensioncohort

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (5)

  • Hypertension

    at enrollment

  • Dyslipidemia

    at enrollment

  • abnormal fasting plasma glucose

    at enrollment

  • abdominal obesity

    at enrollment

  • diabetes mellitus

    at enrollment

Other Outcomes (1)

  • major cardiovascular events

    after follow-up period of 36 months

Study Arms (1)

incident hypertensives

Inclusion Criteria: * age≧30years * primary incident hypertension * signed informed consent

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Korean patients with incident hypertensive, who visited university hospital

You may qualify if:

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

You may not qualify if:

  • participated in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Dongtan Sacred Heart Hospital,

Hwaseong, Gyeonggido, 445-170, South Korea

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Kyu-Hyung Ryu, MD, PhD

    Dongtan Sacred Heart Hospital, Hallym University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kyu-Hyung Ryu, M.D., Professor

Study Record Dates

First Submitted

May 16, 2013

First Posted

May 23, 2013

Study Start

May 1, 2013

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 8, 2019

Record last verified: 2019-02

Locations