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Development of Diagnostic and Treatment Strategy for Resistant Hypertension

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StatusRecruiting
Sponsors
Yonsei University

Keywords

Abstract

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.

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.

Dates

Last Verified: 04/30/2018
First Submitted: 05/02/2018
Estimated Enrollment Submitted: 05/27/2018
First Posted: 05/29/2018
Last Update Submitted: 05/27/2018
Last Update Posted: 05/29/2018
Actual Study Start Date: 02/13/2018
Estimated Primary Completion Date: 02/27/2023
Estimated Study Completion Date: 02/27/2023

Condition or disease

Resistant Hypertension

Phase

-

Eligibility Criteria

Ages Eligible for Study 20 Years To 20 Years
Sexes Eligible for StudyAll
Sampling methodNon-Probability Sample
Accepts Healthy VolunteersYes
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%)

Outcome

Primary Outcome Measures

1. Major adverse cardiac events [3 years]

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

Secondary Outcome Measures

1. Progression of CKD [3 years]

Start dialysis or doubling of serum creatinine

2. 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)

3. Target blood pressure achievement [3 years]

Target blood pressure: Achievement of BP below 130/80 or 140/90 mmHg

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