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

Hypertension Clinical Trial

— PROMISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04135911
• Other study ID #: PROMISE20190831
• Status: Recruiting
• Start date: December 30, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2020
• Source: Shanghai Institute of Hypertension
• Contact: Yan Li, MD, PhD
• Phone: +8621-64370045
• Email: liyanshcn[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Yan Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 years
Secondary	Change in different blood pressure measurement	Differences in workplace blood pressure, daytime ambulatory blood pressure, home blood pressure and 24-hour ambulatory blood pressure	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	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	2 years