The Effect of Home Blood Pressure Measurement on the Management of Hypertension

NCT03868384 | Active Not Recruiting

• 1 other identifier: DUMC-C1801
• Study Type: observational
• Target: 701
• Locations: 1 country
• Sites: 1

Brief Summary

Home blood pressure measurement has been reported to be associated with better clinic blood pressure and daytime blood pressure control. However, no study has evaluated the association between home blood pressure measurement and control of 24-hour ambulatory blood pressure in real world practice. The purpose of the present study is to investigate the effect of home blood pressure measurement on the control of ambulatory blood pressure in the real world. The detailed purposes of the present study are (1) to investigate the effects of home blood pressure measurement on the appropriate control of 24-hour ambulatory blood pressure in hypertensive patients treated with antihypertensive drug, (2) to evaluate the effect of home blood pressure measurement on the occurrence of cardiovascular events and target organ damage, (3) to investigate the status and appropriateness of home blood pressure measurement in the real world, and (4) to investigate factors of home blood pressure measurement methods affecting the treatment of hypertension.

Conditions

Hypertension; Blood Pressure; Home Blood Pressure Measurement; Ambulatory Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Difference of 24-hour blood pressure control rate

  difference of 24-hour blood pressure control rate between patients who measure and do not measure home blood pressure

  at baseline and 3 years of follow up

Secondary Outcomes (8)

• Difference of daytime blood pressure control rate

  at baseline and 3 years of follow up

• Difference of office blood pressure control rate

  at baseline and 3 years of follow up

• Difference of systolic and diastolic blood pressure (office, 24-hour, daytime, nighttime)

  at baseline and 3 years of follow up

• Rate of home blood pressure measurement

  at baseline and 3 years of follow up

• Reflection of home blood pressure

  at baseline and 3 years of follow up

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hypertension who were taking antihypertensive drugs for more than 1 year for treatment of hypertension are recruited through advertising in Goyang City where the hospital is located and Paju City near to the hospital.

You may qualify if:

• Patients with hypertension and taking antihypertensive drugs more than 1 year

You may not qualify if:

• Secondary hypertension
• Hypertensive emergency and urgency
• Severe heart failure (NYHA III and IV)
• Angina with 6 months
• Myocardial infarction within 6 months
• Peripheral artery disease within 6 months
• Significant arrhythmia (i.e. ventricular tachycardia and fibrillation, atrial fibrillation, atrial flutter)
• Pregnancy
• Night labor, shift worker
• Those who are currently participating in other clinical studies
• Those who have taken other clinical trial drugs within the past month
• According to the opinion of the researcher, those who have or may have a disease that may interfere with the completion of the study
• History of drug or alcohol dependence within 6 months

Sponsors & Collaborators

• DongGuk University: lead

Study Sites (1)

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 10326, South Korea

Location

Related Publications (1)

• Rhee MY, Munakata M, Nah DY, Kim JS, Kim HY. Home blood pressure measurement for hypertension management in the real world: Do not just measure, but share with your physician. Front Cardiovasc Med. 2023 Jan 18;10:1103216. doi: 10.3389/fcvm.2023.1103216. eCollection 2023.

  PMID: 36742078 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 11, 2019
• Study Start: August 1, 2018
• Primary Completion: May 13, 2020
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)