- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04135911
A Prospective Study on the"Management of Hypertension in Young and Middle-aged Subjects in Enterprises Setting" (PROMISE)
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 Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Recruiting
- Ruijin Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in different blood pressure measurement
Time Frame: 2 years
|
Differences in workplace blood pressure, daytime ambulatory blood pressure, home blood pressure and 24-hour ambulatory blood pressure
|
2 years
|
The distribution of heart rate in young and middle-aged subjects
Time Frame: 2 years
|
The distribution of heart rate in young and middle-aged subjects who were diagnosed with hypertension
|
2 years
|
Progression of target organ damage
Time Frame: 2 years
|
Differences in the progression of target organ damage between controlled or uncontrolled subjects or between subjects with fast and slow heart rate
|
2 years
|
The development of with-coat hypertension
Time Frame: 2 years
|
The development of white-coat hypertension as persistent hypertension and other types of hypertension or normal blood pressure and changes in target organ damage
|
2 years
|
The proportion of masked hypertension in patients with normal high blood pressure
Time Frame: 2 years
|
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
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROMISE20190831
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Recruiting
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom