Wearable Blood Pressure Devices to Identify Masked Uncontrolled Hypertension.

April 26, 2021 updated by: National Taiwan University Hospital Hsin-Chu Branch

Application of the HeartGuide Blood Pressure Watch Monitor to Identify Masked Uncontrolled Hypertension in Hypertensive Patients With Different Cardiovascular Risks In Taiwan.

Uncontrolled out-of-office blood pressure (BP), measured by either home BP monitoring (HBPM) or ambulatory BP monitoring, has been shown to predict higher cardiovascular risk. However, HBPM could not identify daytime BP surge, which leads to underestimation of future risk among treated hypertensive individuals.

HeartGuide provides validated out-of-office BP measurements, along with activity/sleep recordings. The present study is designed to examine whether BP monitoring with the HeartGuide could identify masked uncontrolled hypertension in controlled hypertensive patients based on office BP. We will enroll hypertensive patients with controlled office BP according to their cardiovascular risk profile. We will also examine prevalence of post-prandial BP changes and BP variability using HeartGuide.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Recent hypertension guidelines stressed the importance of out-of-office BP monitoring. Ambulatory BP (ABPM) and home BP monitoring (HBPM) both predict future cardiovascular events better than office BP. Masked hypertension is an important issue. As revealed by recent studies, daytime BP surge can result in greater target organ damage for high-risk hypertensive individuals.

Previous trials such as TASMINH2 and TASMINH-SR study showed positive effects of HBPM on BP control in hypertensive patients. However, several issues preclude perfect applications of HBPM. For example, HBPM could not provide BP recordings during activity or at night-time. In addition, the currently recommended time schedule for HBPM may be insufficient for detecting daytime surge especially among high-risk individuals. Wearable BP devices seem to fill in this gap as a novel approach of out-of-office monitoring.

HeartGuide, the new watch BP monitor, was recently validated to provide accurate BP measurements. It could provide incremental knowledge with potentially larger numbers of recordings. The primary objective of this study is to unveil uncontrolled masked hypertension with HeartGuide, particularly for those undetected with current office BP and HBPM. A second objective is to assess diurnal BP trends and BP variability.

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Hsinchu, Taiwan, 300
        • Recruiting
        • National Taiwan University Hospital Hsin-Chu Branch
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants routinely treated at out-patient clinics for hypertension are to be enrolled after informed consent.

Description

Inclusion Criteria:

  • Willing to sign informed consent form
  • Currently taking anti-hypertensive therapy for more than 3 months
  • Drugs are unchanged during the study period
  • Office BP below 140/90 mmHg at least one visit

Exclusion Criteria:

  • Diagnosed with terminal illness
  • End-stage renal disease requiring lifelong dialysis treatment
  • Patients with impaired performance status (ECOG >= 2)
  • Women undergoing or expecting pregnancy during the study period
  • Resistant hypertension (taking more than 4 kinds of anti-hypertensive drugs)
  • Known atrial or ventricular arrhythmia
  • Wrist circumference out-of range between 13.5 to 21.5 cm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Low-risk hypertensive patients
Patients without diabetes, chronic kidney disease, hypertension-mediated organ damage, or established cardiovascular diseases
With-risk hypertensive patients
Patients with diabetes, chronic kidney disease, hypertension-mediated organ damage, but without established cardiovascular diseases
Hypertensive patients with cardiovascular diseases
Patients with established cardiovascular diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of masked uncontrolled hypertension
Time Frame: during 3-month follow-up period
measured BP>=135/85 mmHg by wearable BP devices or average BP>=130/80 mmHg by ambulatory BP monitor
during 3-month follow-up period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Newly diagnosed left ventricular hypertrophy by echocardiography
Time Frame: at 3-month follow-up
left ventricular mass index>=115 g/m2(men) or >=95 g/m2(women)
at 3-month follow-up
Occurrence of post-prandial BP change
Time Frame: during 3-month follow-up period
measured BP drop >= 20 mmHg pre- and post-meal
during 3-month follow-up period
BP variability
Time Frame: during 3-month follow-up period
coefficient of variation of all measured BP values by either HeartGuide or ambulatory BP monitor
during 3-month follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital Hsin-Chu Branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2020

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109-029-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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