Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135911
Recruitment Status : Not yet recruiting
First Posted : October 23, 2019
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Yan Li, Shanghai Institute of Hypertension

Brief 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.

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.


Condition or disease
Hypertension Blood Pressure

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: A Prospective Study on the"Management of Hypertension in Young and Middle-aged Subjects in Enterprises Setting"
Estimated Study Start Date : October 30, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients measuring blood pressure at the workplace with normal high blood pressure or hypertensive patients.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135911


Contacts
Layout table for location contacts
Contact: Yan Li, MD, PhD +8621-64370045 ext 663201 liyanshcn@163.com

Sponsors and Collaborators
Yan Li
Layout table for additonal information
Responsible Party: Yan Li, Professor of Cardiovascular Medicine, Shanghai Institute of Hypertension
ClinicalTrials.gov Identifier: NCT04135911    
Other Study ID Numbers: PROMISE20190831
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases