A Prospective Study on the"Management of Hypertension in Young and Middle-aged Subjects in Enterprises Setting" (PROMISE)

October 26, 2020 updated by: Yan Li

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

Unknown

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients measuring blood pressure at the workplace with normal high blood pressure or hypertensive patients.

Description

Inclusion Criteria:

  1. Male and female sex, aged 18-65 years
  2. Three different daytime workplace blood pressure measurements meet the limits: systolic blood pressure ≥ 120 mmHg, or diastolic blood pressure ≥80 mmHg
  3. Hypertensive patients who are taking antihypertensive drugs
  4. Willing to provide information about disease history and lifestyle
  5. Willing to receive follow-up for up to 2-3 years
  6. Sign the informed consent

Exclusion Criteria:

  1. Having the onset of cardiovascular and cerebrovascular diseases such as stroke, myocardial infarction or heart failure within 6 months
  2. Having a history of atrial fibrillation or frequent arrhythmia
  3. 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
  4. The subject is participating in other clinical studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 30, 2019

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

October 21, 2019

First Posted (ACTUAL)

October 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2020

Last Update Submitted That Met QC Criteria

October 26, 2020

Last Verified

October 1, 2020

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

No

Studies a U.S. FDA-regulated device product

No

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.

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