Screening for Masked Hypertension With Smart Wearable Devices (SMART)

NCT ID: NCT05409898

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2024-07-31

Brief Summary

In recent years, a large number of consumer-grade and Smart Wearable Devices (SWD) such as smart watches, with BP measurement property, have entered the market and have a high configuration and utilization among young and middle-aged populations, but most of them are uncalibrated and have poor accuracy. Recently, several medical-grade smart BP watches have passed the national medical device registration test, which will provide an important tool for accurate screening of hypertension, especially masked hypertension, in young and middle-aged people.

"Screening for masked hypertension in young and middle-aged adults with smart wearable devices" （SMART）aims to screen for masked hypertension using smart BP watches that have been tested for national medical device registration. It is planned to include 200 young and middle-aged subjects with normal blood pressure (BP) in the clinic, who will wear the smart BP watch for 7 consecutive days (BP will be measured at least once in the morning and once in the evening, 2-3 times each time), and if the mean BP is >= 135/85 mmHg, it will be determined to be MK and recommended for further consultation and treatment.

Detailed Description

Masked hypertension (MH) is defined as elevated ambulatory or home blood pressure (BP), but normal office BP, often complicated with severe cardiovascular and renal damage. MH is easily missed and needs to be identified by "out-of-office" BP measurements such as ambulatory BP monitoring (ABPM) or home BP monitoring (HBPM). However, in clinical practice, ABPM has poor accessibility, high cost, and requires appointments, making it difficult to meet the demand; HBPM has better accessibility, but low utilization and irregular use are more prominent. In addition, these devices interfere with sleep and activity when measuring BP, so their clinical application is somewhat limited.

Smart wearable devices (SWD) can sense and record various physiological parameters of human body, and analyze the health status of individuals with the support of software algorithms. In recent years, a large number of consumer-grade and SWD such as smart watches, with BP measurement property, have entered the market and have a high configuration and utilization among young and middle-aged populations, but most of them are uncalibrated and have poor accuracy. Recently, several medical-grade smart BP watches have passed the national medical device registration test, which will provide an important tool for accurate screening of hypertension, especially MH, in young and middle-aged people.

"Screening for masked hypertension in young and middle-aged adults with smart wearable devices" （SMART） aims to screen for MH using smart BP watches that have been tested for national medical device registration. It is planned to include 200 young and middle-aged subjects with normal blood pressure in the clinic, who will wear the smart BP watch for 7 consecutive days (BP will be measured at least once in the morning and once in the evening, 2-3 times each time), and if the mean BP is >= 135/85 mmHg, it will be determined to be MK and recommended for further consultation and treatment.

Conditions

Masked Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

smart wearable device

screening masked hypertension with smart wearable devices

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 18-50 years of age, male or female

2. No clear previous history of hypertension and other cardiovascular diseases

3. Signed informed consent form

Exclusion Criteria

1. Patients with established hypertension

2. History of severe heart, liver, or kidney disease

3. Inability to cooperate in completing the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HUAWEI

UNKNOWN

Sponsor Role: collaborator

Jing Liu

OTHER

Sponsor Role: lead

Responsible Party

Jing Liu

Director of the Department of Hypertension

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jing Liu, MD

Role: STUDY_CHAIR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, , China

Countries

China

Central Contacts

Jing Liu, MD

Role: CONTACT

heartcenter@163.com

01088325457

Other Identifiers

2022PHB108

Identifier Type: -

Identifier Source: org_study_id