Development of Diagnostic and Treatment Strategy for Resistant Hypertension

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.

Study Overview

• Status: Unknown
• Conditions: Resistant Hypertension

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 Type: Observational
• Enrollment (Anticipated): 780

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Division of Cardiology Severance Cardiovascular Hospital
    • Contact: Sungha Park, MD; Phone Number: 82-2-2228-8455; Email: shpark0530@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A pateint diagnosed with resistant hypertension

Description

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%)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac events	Composite of cardiovascular death, myocardial infarction, stroke, admission for heart fails	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of CKD	Start dialysis or doubling of serum creatinine	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)	3 years
Target blood pressure achievement	Target blood pressure: Achievement of BP below 130/80 or 140/90 mmHg	3 years

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• 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. Erratum In: J Clin Hypertens (Greenwich). 2022 Jan;24(1):91-96.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2018
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: May 28, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 28, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 4-2017-1222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No