Masked HypertensionSMARTNCT05409898
Screening for Masked Hypertension With Smart Wearable Devices (SMART)
An observational study of Masked Hypertension, run by Jing Liu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Masked Hypertension
- What is being tested?
- smart wearable device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jul 2022to Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 18-50 years of age, male or female
- No clear previous history of hypertension and other cardiovascular diseases
- Signed informed consent form
Who cannot join
- Patients with established hypertension
- History of severe heart, liver, or kidney disease
- Inability to cooperate in completing the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Masked Hypertension in Young and Middle-aged Adults With Smart Wearable Devices (SMART)
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.
Read the 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
- Being tested
- smart wearable device
- Keywords
- asked hypertension, Smart wearable device
- Medical subject headings
- Masked Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart wearable deviceDevice
screening masked hypertension with smart wearable devices
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (1)
Prevalence of 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, the diagnosis will be "Hypertension".
The prevalence of hypertension will be calculated as the following:
number of hypertension/number of subjects included.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study startJul 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Masked HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Liu
- Sponsor type
- University, hospital or other
- Collaborators
- HUAWEI
- Responsible party
- Sponsor-investigator, Jing Liu, Peking University People's Hospital
- Investigators
- Jing Liu, MD, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409898
- Sponsor's protocol ID
- 2022PHB108
- Acronym
- SMART
- Status last verified
- Jun 2022
- First submitted
- 3 Jun 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Masked Hypertension in Young and Middle-aged Adults With Smart Wearable Devices (SMART)
- ClinicalTrials.gov ID
- NCT05409898
- Acronym / sponsor ID
- SMART / 2022PHB108
- Conditions
- Masked Hypertension
- Keywords
- asked hypertension, Smart wearable device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jing LiuUniversity, hospital or other
- Collaborators
- HUAWEI
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 18-50 years of age, male or female
- No clear previous history of hypertension and other cardiovascular diseases
- Signed informed consent form
Key exclusion criteria (3 listed)
- Patients with established hypertension
- History of severe heart, liver, or kidney disease
- Inability to cooperate in completing the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smart wearable devicescreening masked hypertension with smart wearable devices | Device | – |
Primary outcome
Prevalence of masked hypertension
Time frame: 7 days
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.
1 secondary outcome
Prevalence of hypertension
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Liu, MD study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Masked Hypertension, run by Jing Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Liu, MD (01088325457, heartcenter@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of masked hypertension (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.