Development of Diagnostic and Treatment Strategy for Resistant Hypertension

Resistant Hypertension Clinical Trial

Official title:

Development of Diagnostic and Treatment Strategy for Resistant Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03540992
• Other study ID #: 4-2017-1222
• Status: Recruiting
• Start date: February 14, 2018
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2018
• Source: Yonsei University
• Contact: Sungha Park, MD
• Phone: 82-2-2228-8455
• Email: shpark0530[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 780
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology Severance Cardiovascular Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events	Composite of cardiovascular death, myocardial infarction, stroke, admission for heart fails	3 years
Secondary	Progression of CKD	Start dialysis or doubling of serum creatinine	3 years
Secondary	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)	3 years
Secondary	Target blood pressure achievement	Target blood pressure: Achievement of BP below 130/80 or 140/90 mmHg	3 years