HypertensionPROMISENCT04135911
A Prospective Study on The"Management of Hypertension in Young and Middle-aged Subjects in Enterprises Setting"
An observational study of Hypertension and Blood Pressure, run by Yan Li at 1 site in China.
Trial summary
In recent years, with the investment from government in the health management of the elderly, community management of hypertension in the elderly has made great progress in management rate and standardized management, but the management of young and middle-aged patients with hypertension is still blank. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Blood Pressure
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2019to 31 Mar 2026
- How long will I take part?
- 2 Years
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients measuring blood pressure at the workplace with normal high blood pressure or hypertensive patients.
Who may be able to join
- Male and female sex, aged 18-65 years
- Three different daytime workplace blood pressure measurements meet the limits: systolic blood pressure ≥ 120 mmHg, or diastolic blood pressure ≥80 mmHg
- Hypertensive patients who are taking antihypertensive drugs
- Willing to provide information about disease history and lifestyle
- Willing to receive follow-up for up to 2-3 years
- Sign the informed consent
Who cannot join
- Having the onset of cardiovascular and cerebrovascular diseases such as stroke, myocardial infarction or heart failure within 6 months
- Having a history of atrial fibrillation or frequent arrhythmia
- Complicating other diseases that are not suitable for the trial, such as thyroid disease with active medication, acute infectious diseases, chronic mental illness, and tumors
- The subject is participating in other clinical studies.
Trial locations and contacts
1 site in 1 country.
About this study
In recent years, with the investment from government in the health management of the elderly, community management of hypertension in the elderly has made great progress in management rate and standardized management, but the management of young and middle-aged patients with hypertension is still blank.
Workplace pressure measurement may be more suitable for most of the young and middle-aged patients to find high blood pressure and monitor blood pressure changes in time.
However, there is not much research on workplace pressure measurement. Whether blood pressure measurement in the workplace can reduce the white coat effect, and how it relates to home blood pressure and ambulatory blood pressure is still unclear.
- Conditions
- Hypertension, Blood Pressure
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic classification in hypertension
Differences in diagnostic classification between workplace blood pressure and daytime ambulatory blood pressure in the classification of hypertension (masked hypertension or white coat hypertension)
Measured: 2 years
Secondary outcomes (5)
Change in different blood pressure measurement
Differences in workplace blood pressure, daytime ambulatory blood pressure, home blood pressure and 24-hour ambulatory blood pressure
Measured: 2 years
The distribution of heart rate in young and middle-aged subjects
The distribution of heart rate in young and middle-aged subjects who were diagnosed with hypertension
Measured: 2 years
Progression of target organ damage
Differences in the progression of target organ damage between controlled or uncontrolled subjects or between subjects with fast and slow heart rate
Measured: 2 years
The development of with-coat hypertension
The development of white-coat hypertension as persistent hypertension and other types of hypertension or normal blood pressure and changes in target organ damage
Measured: 2 years
The proportion of masked hypertension in patients with normal high blood pressure
The proportion of masked hypertension in patients with normal high blood pressure and the change in outcome after treatment intervention and changes in target organ damage
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start30 Dec 2019
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Why it stopped: The study was suspended due to limited funding and the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 2,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Yan Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Li, Shanghai Institute of Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135911
- Sponsor's protocol ID
- PROMISE20190831
- Acronym
- PROMISE
- Status last verified
- Jan 2025
- First submitted
- 21 Oct 2019
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on The"Management of Hypertension in Young and Middle-aged Subjects in Enterprises Setting"
- ClinicalTrials.gov ID
- NCT04135911
- Acronym / sponsor ID
- PROMISE / PROMISE20190831
- Conditions
- Hypertension, Blood Pressure
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: The study was suspended due to limited funding and the COVID-19 pandemic.
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Yan LiUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 23 Oct 2019 (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, with the investment from government in the health management of the elderly, community management of hypertension in the elderly has made great progress in management rate and standardized management, but the management of young and middle-aged patients with hypertension is still blank.
Workplace pressure measurement may be more suitable for most of the young and middle-aged patients to find high blood pressure and monitor blood pressure changes in time.
However, there is not much research on workplace pressure measurement. Whether blood pressure measurement in the workplace can reduce the white coat effect, and how it relates to home blood pressure and ambulatory blood pressure is still unclear.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients measuring blood pressure at the workplace with normal high blood pressure or hypertensive patients.
Key inclusion criteria (6 listed)
- Male and female sex, aged 18-65 years
- Three different daytime workplace blood pressure measurements meet the limits: systolic blood pressure ≥ 120 mmHg, or diastolic blood pressure ≥80 mmHg
- Hypertensive patients who are taking antihypertensive drugs
- Willing to provide information about disease history and lifestyle
- Willing to receive follow-up for up to 2-3 years
Key exclusion criteria (4 listed)
- Having the onset of cardiovascular and cerebrovascular diseases such as stroke, myocardial infarction or heart failure within 6 months
- Having a history of atrial fibrillation or frequent arrhythmia
- Complicating other diseases that are not suitable for the trial, such as thyroid disease with active medication, acute infectious diseases, chronic mental illness, and tumors
- The subject is participating in other clinical studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic classification in hypertension
Time frame: 2 years
Differences in diagnostic classification between workplace blood pressure and daytime ambulatory blood pressure in the classification of hypertension (masked hypertension or white coat hypertension)
5 secondary outcomes
Change in different blood pressure measurement
Time frame: 2 years
The distribution of heart rate in young and middle-aged subjects
Time frame: 2 years
Progression of target organ damage
Time frame: 2 years
The development of with-coat hypertension
Time frame: 2 years
The proportion of masked hypertension in patients with normal high blood pressure
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypertension and Blood Pressure, run by Yan Li 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 6 inclusion and 4 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: paused, as of the sponsor's last update on 9 Jan 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic classification in hypertension (time frame: 2 years). 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 9 Jan 2025.