Clinical trial NCT01861080: Korean Registry of Target Organ Damages in Hypertension
Official title: Observational Study of Clinical Characteristics and Prognostic Factors of Korean Hypertensives
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Keywords: target organ damage
incident hypertension
cohort
Lead sponsor: Dongtan Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 3000
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean patients with incident hypertensive, who visited university 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* participated in other clinical trials

Primary outcomes:
measure: left ventricular hypertrophy
timeFrame: at enrollment
measure: Intima media thickness of carotid artery
timeFrame: at enrollment
measure: pulse wave velocity
timeFrame: at enrollment
measure: kidney function
timeFrame: at enrollment
measure: cerebrovascular accident
timeFrame: at enrollment
measure: renal disease
timeFrame: at enrollment
measure: peripheral artery disease
timeFrame: at enrollment
measure: retinopathy
timeFrame: at enrollment
Secondary outcomes:
measure: Hypertension
timeFrame: at enrollment
measure: Dyslipidemia
timeFrame: at enrollment
measure: abnormal fasting plasma glucose
timeFrame: at enrollment
measure: abdominal obesity
timeFrame: at enrollment
measure: diabetes mellitus
timeFrame: at enrollment
Other outcomes:
measure: major cardiovascular events
timeFrame: after follow-up period of 36 months
Locations:
city: Hwaseong
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital,
state: Gyeonggido
Study officials:
affiliation: Dongtan Sacred Heart Hospital, Hallym University
name: Kyu-Hyung Ryu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.