Screening for Masked Hypertension With Smart Wearable Devices (SMART)

NCT05409898 | Unknown

• 1 other identifier: 2022PHB108
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Masked Hypertension

Keywords

asked hypertension, Smart wearable device

Outcome Measures

Primary Outcomes (1)

• Prevalence of masked hypertension

  Average systolic/diastolic BP during 7 days of the observation period will be calculated. Office BP should be measured when the average BP is ≥135/85 mmHg during 7 days of continuous self-monitoring. If the office BP is \< 140/90 mmHg at visit, "Masked Hypertension" will be diagnosed. The prevalence of masked hypertension will be calculated as the following: number of masked hypertension/number of subjects included.

  7 days

Secondary Outcomes (1)

• Prevalence of hypertension

  7 days

Interventions

smart wearable device DEVICE

screening masked hypertension with smart wearable devices

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be recruited in the hospital in the volunteers who are interested in this project or those who are concern of the hypertension despite with norm tension during usual physical examinations.

You may qualify if:

• years of age, male or female
• No clear previous history of hypertension and other cardiovascular diseases
• Signed informed consent form

You may not qualify if:

• Patients with established hypertension
• History of severe heart, liver, or kidney disease
• Inability to cooperate in completing the study

Sponsors & Collaborators

• Jing Liu: lead
• HUAWEI: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

MeSH Terms

Conditions

Masked Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jing Liu, MD

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Jing Liu, MD

CONTACT

01088325457; heartcenter@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Department of Hypertension

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 8, 2022
• Study Start: July 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)