Resistant HypertensionNCT03540992
Development of Diagnostic and Treatment Strategy for Resistant Hypertension
An observational study of Resistant Hypertension, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Resistant Hypertension
- How many people
- 780 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Feb 2018to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A pateint diagnosed with resistant hypertension
Who may be able to join
- 20 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
Who cannot join
- 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%)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology Severance Cardiovascular Hospital
Seoul, 03722
Sungha Park, MD, 82-2-2228-8455, shpark0530@yuhs.ac
About this study
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.
Read the detailed description
This study will enroll hypertensive patients who are in treatment or those who are referred from primary clinic based on inclusion or exclusion criteria. Basic clinical information, compliance with antihypertensive medications, concomitant use of other medications will be investigated and all patients will perform 24-hr ambulatory blood pressure measurement. Screening for renal artery stenosis and primary aldosteronism will be conducted. Office blood pressure will be taken every 3-6 months. Home blood pressure measurement and 24-hr ambulatory blood pressure measurement will be performed every year. The primary outcome is the newly developed MACE during the follow-up period. The secondary outcomes are newly developed target organ damage (LVH confirmed by echocardiography or EKG, carotid femoral PWV≥ 12m/s, microalbuminuria (Urine albumin-creatinine ratio ≥30 mg/g)) and decline of renal function (doubling of serum creatinine, dialysis). The follow-up period is 3 years.
- Conditions
- Resistant Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Composite of cardiovascular death, myocardial infarction, stroke, admission for heart fails
Measured: 3 years
Secondary outcomes (3)
Progression of CKD
Start dialysis or doubling of serum creatinine
Measured: 3 years
Target organ damages
Target organ damage: LVH confirmed by echocardiography or EKG; carotid femoral PWV≥ 12m/s; microalbuminuria (Urine albumin-creatinine ratio ≥30 mg/g)
Measured: 3 years
Target blood pressure achievement
Target blood pressure: Achievement of BP below 130/80 or 140/90 mmHg
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start14 Feb 2018
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540992
- Sponsor's protocol ID
- 4-2017-1222
- Status last verified
- May 2018
- First submitted
- 3 May 2018
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seo J, Lee CJ, Kim DH, Kim SY, Moon JY, Park JH, Son JW, Kim JY, Kim IC, Rhee MY, Lee JH, Lee HY, Chung JW, Ihm SH, Choi JH, Shin J, Park S. Discrepancies between home blood pressure and ambulatory blood pressure monitoring in apparent treatment-resistant hypertension: analysis from the Korean resistant hypertension cohort. Hypertens Res. 2025 Jan;48(1):37-48. doi: 10.1038/s41440-024-02017-7. Epub 2024 Nov 14.
PubMed 39543419Lee 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.
PubMed 33280228
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Diagnostic and Treatment Strategy for Resistant Hypertension
- ClinicalTrials.gov ID
- NCT03540992
- Acronym / sponsor ID
- 4-2017-1222
- Conditions
- Resistant Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will enroll hypertensive patients who are in treatment or those who are referred from primary clinic based on inclusion or exclusion criteria. Basic clinical information, compliance with antihypertensive medications, concomitant use of other medications will be investigated and all patients will perform 24-hr ambulatory blood pressure measurement. Screening for renal artery stenosis and primary aldosteronism will be conducted. Office blood pressure will be taken every 3-6 months. Home blood pressure measurement and 24-hr ambulatory blood pressure measurement will be performed every year. The primary outcome is the newly developed MACE during the follow-up period. The secondary outcomes are newly developed target organ damage (LVH confirmed by echocardiography or EKG, carotid femoral PWV≥ 12m/s, microalbuminuria (Urine albumin-creatinine ratio ≥30 mg/g)) and decline of renal function (doubling of serum creatinine, dialysis). The follow-up period is 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A pateint diagnosed with resistant hypertension
Key inclusion criteria (3 listed)
- 20 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiac events
Time frame: 3 years
Composite of cardiovascular death, myocardial infarction, stroke, admission for heart fails
3 secondary outcomes
Progression of CKD
Time frame: 3 years
Target organ damages
Time frame: 3 years
Target blood pressure achievement
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Derived from this study: PubMed 39543419Seo J, Lee CJ, Kim DH, Kim SY, Moon JY, Park JH, Son JW, Kim JY, Kim IC, Rhee MY, Lee JH, Lee HY, Chung JW, Ihm SH, Choi JH, Shin J, Park S. Discrepancies between home blood pressure and ambulatory blood pressure monitoring in apparent treatment-resistant hypertension: analysis from the Korean resistant hypertension cohort. Hypertens Res. 2025 Jan;48(1):37-48. doi: 10.1038/s41440-024-02017-7. Epub 2024 Nov 14.
- Derived from this study: PubMed 33280228Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resistant Hypertension, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sungha Park, MD (82-2-2228-8455, shpark0530@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03540992, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.