Development of Diagnostic and Treatment Strategy for Resistant Hypertension

NCT ID: NCT03540992

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 780 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-14
• Study Completion Date: 2023-02-28

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.

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

Study Design

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

Eligibility Criteria

Inclusion Criteria

1. 20 years and older

2. Office SBP>130 mmHg or office DBP >90 mmHg with 3 antihypertensive medications of different classes

3. Treated hypertensive patients with 4 antihypertensive medications of difference classes including diuretics

Exclusion Criteria

1. desired life time under 6 months due to non-cardiovascular disease (e.g. cancer, sepsis)

2. women with pregnancy or on nursing

3. within the first three months after transplantation

4. acute renal allograft rejection

5. within six months after discharge from hospitalization for acute coronary syndrome (myocardial infarction, unstable angina) or acute stroke

6. systolic heart failure (LVEF ≤40%)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Cardiology Severance Cardiovascular Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sungha Park, MD

Role: CONTACT

shpark0530@yuhs.ac

82-2-2228-8455

Facility Contacts

Sungha Park, MD

Role: primary

shpark0530@yuhs.ac

82-2-2228-8455

References

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.

Reference Type: DERIVED

PMID: 33280228 (View on PubMed)

Other Identifiers

4-2017-1222

Identifier Type: -

Identifier Source: org_study_id