NCT03540992

Brief Summary

This study is a registry study to examine the clinical features, blood pressure control rate, and clinical prognosis of resistant hypertension in Koreans. This study will register patients with resistance hypertension in eight tertiary hospitals in Korea and follow up them for three years. The prognosis will be analysed according to etiologies, achieved blood pressure, and types of antihypertensive medication.

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
780

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

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

February 14, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

5 years

First QC Date

May 3, 2018

Last Update Submit

May 28, 2018

Conditions

Resistant Hypertension

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

    Composite of cardiovascular death, myocardial infarction, stroke, admission for heart fails

    3 years

Secondary Outcomes (3)

  • Progression of CKD

    3 years

  • Target organ damages

    3 years

  • Target blood pressure achievement

    3 years

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A pateint diagnosed with resistant hypertension

You may qualify if:

  • years and older
  • Office SBP\>130 mmHg or office DBP \>90 mmHg with 3 antihypertensive medications of different classes
  • Treated hypertensive patients with 4 antihypertensive medications of difference classes including diuretics

You may not qualify if:

  • desired life time under 6 months due to non-cardiovascular disease (e.g. cancer, sepsis)
  • women with pregnancy or on nursing
  • within the first three months after transplantation
  • acute renal allograft rejection
  • within six months after discharge from hospitalization for acute coronary syndrome (myocardial infarction, unstable angina) or acute stroke
  • systolic heart failure (LVEF ≤40%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology Severance Cardiovascular Hospital

Seoul, 03722, South Korea

RECRUITING

Related Publications (1)

  • Lee CJ, Ha JH, Kim JY, Kim IC, Ryu SK, Rhee MY, Lee JH, Lee JH, Lee HY, Ihm SH, Chung JW, Choi JH, Shin J, Park S, Kario K. Office blood pressure threshold of 130/80 mmHg better predicts uncontrolled out-of-office blood pressure in apparent treatment-resistant hypertension. J Clin Hypertens (Greenwich). 2021 Mar;23(3):595-605. doi: 10.1111/jch.14113. Epub 2020 Dec 5.

    PMID: 33280228DERIVED

Central Study Contacts

Sungha Park, MD

CONTACT

82-2-2228-8455shpark0530@yuhs.ac

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 30, 2018

Study Start

February 14, 2018

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

KR(1)