Wearable Blood Pressure Devices to Identify Masked Uncontrolled Hypertension.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-26

Study Completion Date

2021-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies

NCT03578848

Hypertension

UNKNOWN NA

Screening for Masked Hypertension With Smart Wearable Devices (SMART)

NCT05409898

Masked Hypertension

UNKNOWN

Home Versus Ambulatory Monitoring, Diurnal Blood Pressure Profile, Detection of Non-Dippers

NCT01460732

Hypertension

COMPLETED NA

Comparing PPG-based Blood Pressure Measurement to the Gold Standard Manometer

NCT03810586

Hypertension Blood Pressure Disorders

COMPLETED NA

Validation of Noninvasive Blood Pressure Device

NCT04676152

Healthy Hypertension Hypotension

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension,Essential Hypertension, Masked

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low-risk hypertensive patients

Patients without diabetes, chronic kidney disease, hypertension-mediated organ damage, or established cardiovascular diseases

No interventions assigned to this group

With-risk hypertensive patients

Patients with diabetes, chronic kidney disease, hypertension-mediated organ damage, but without established cardiovascular diseases

No interventions assigned to this group

Hypertensive patients with cardiovascular diseases

Patients with established cardiovascular diseases

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No