Development of Diagnostic and Treatment Strategy for Resistant Hypertension

• Conditions: Resistant Hypertension

• Registration Number: NCT03540992
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2018-02-14
• Status Verified: 2018-05
• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-28
• Last Update Submitted: 2018-05-28
• Study First Posted: 2018-05-30
• Last Update Posted: 2018-05-30
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 780

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

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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%)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events	3 years	Composite of cardiovascular death, myocardial infarction, stroke, admission for heart fails

Secondary Outcome Measures

Name	Time	Method
Target blood pressure achievement	3 years	Target blood pressure: Achievement of BP below 130/80 or 140/90 mmHg
Progression of CKD	3 years	Start dialysis or doubling of serum creatinine
Target organ damages	3 years	Target organ damage: LVH confirmed by echocardiography or EKG; carotid femoral PWV≥ 12m/s; microalbuminuria (Urine albumin-creatinine ratio ≥30 mg/g)

Trial Locations

Locations (1)

Division of Cardiology Severance Cardiovascular Hospital; 🇰🇷 Seoul, Korea, Republic of