NCT04135911

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 30, 2019

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

6.3 years

First QC Date

October 21, 2019

Last Update Submit

January 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in different blood pressure measurement

    2 years

  • The distribution of heart rate in young and middle-aged subjects

    2 years

  • Progression of target organ damage

    2 years

  • The development of with-coat hypertension

    2 years

  • The proportion of masked hypertension in patients with normal high blood pressure

    2 years

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Cardiovascular Medicine

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 23, 2019

Study Start

December 30, 2019

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations