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Blood Pressure Monitoring, AmbulatoryTRACANCT07740434

Work-Related Frustration and Higher Cardiovascular Risk Blood Pressure Profiles

An observational study of Blood Pressure Monitoring, Ambulatory and Cardiovascular (CV) Risk, run by University of Burgundy at 3 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Background: Mental health is a national priority in France, especially in the workplace. The impact of poor quality of life at work on mental health has been demonstrated. Raising awareness of the importance of prevention within companies and the influence of working conditions seems essential. Read more about this study

Who is it for?
Ages 40 to 65 yearsHealthy volunteers can take part
How many people
316 participants
Where
3 sitesFrance
Study dates
22 May 2023to May 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Primary care working patients in primary cardiovascular prevention

Who may be able to join

  • Patients aged 40 to 65 years
  • Consulting one of the participating general practitioners,
  • Actively working
  • Without cardiovascular history or antihypertensive treatment

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

France3 sites, 3 recruiting
  • Maison Universitaire de Santé et de Soins Primaires

    Chenôve, 21300

    Claire ZABAWA, Dr, +33380525206, clairezabawa@orange.fr

    Recruiting
  • Cabinet médical

    Chevigny-Saint-Sauveur, 21800

    Claire ZABAWA, Dr, +33380393491, clairezabawa@orange.fr

    Recruiting
  • Maison de Santé Pluriprofessionnelle

    Pouilly-en-Auxois, 21320

    Claire ZABAWA, Dr, +33380393491, clairezabawa@orange.fr

    Recruiting

Other trials in France

About this study

Official title: Work-Related Frustration and Higher Cardiovascular Risk Blood Pressure Profiles: A Regional Proof-of-Concept Study on Work-Related Quality of Life and Cardiovascular Prevention.

Background: Mental health is a national priority in France, especially in the workplace. The impact of poor quality of life at work on mental health has been demonstrated. Raising awareness of the importance of prevention within companies and the influence of working conditions seems essential. In the context of limited occupational health physicians, inherent access difficulties, and reduced resources, physical health is often addressed as the first line of intervention. In the Burgundy region, the prevention of cardiovascular diseases is a regional public health concern. A significant association has been found between effort/reward imbalance and masked hypertension. Identifying a link between working conditions, blood pressure profile, and thus increased cardiovascular risk would be relevant.

Objectives: The main goal of this observational study is to compare the frequency of blood pressure profiles at higher risk of cardiovascular events (white coat hypertension and daytime and/or nighttime masked hypertension) according to work-related quality of life and perceived stress levels among primary care patients without a history of hypertension or cardiovascular disease, in two departments of the Burgundy region.

Read more

Methods: This project is a proof-of-concept study before intervention on work-related quality of life and blood pressure profiles at higher cardiovascular risk in primary prevention. It is a prospective, interventional, and multicenter study, conducted from May 2023, across three multidisciplinary primary care centers, involving fifteen general practitioners from Côte d'Or and Saône-et-Loire. Patients aged 40 to 65, consulting one of the participating general practitioners, actively working, with no cardiovascular history or antihypertensive treatment, will be included. Work-related quality of life and perceived stress will be assessed using the QualTra-Scale and the PSS-10 scale, respectively. All included patients will undergo 24-hour ambulatory blood pressure monitoring (ABPM) during a workday. A qualitative component will complement the results through patients' individual interviews exploring ABPM perception and reasons for refusal, and focus groups involving general practitioners and occupational health professionals to explore perceptions and potential intervention strategies.

Perspectives: The main perspective of this study is to focus on workplace health by providing additional data on the physical repercussions of poor work-related quality of life and high perceived stress. Objectifying a confirmed medical situation could serve as a lever for identifying mental health issues. It would enable interventions to improve work-related quality of life by addressing health determinants and psychosocial risks. Various interventions could be considered through a multidisciplinary approach in the workplace, involving occupational physicians, occupational psychologists, and employers. This study could also offer insights into patient profiles at higher cardiovascular risk, help develop recommendations for screening masked hypertension, and evaluate the role of blood pressure measurements at the workplace.

Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07740434
Study groupRoleWhat they receive
Workers from 40 to 65 years, in primary cardiovascular prevention, consulting at general practiceWorking patients consulting at one of the research primary care centers, aged 40 to 65 years, with no history of hypertension or cardiovascular disease, and not taking antihypertensive medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of masked hypertension

    Normal office blood pressure (BP <140/90 mmHg) AND 24-hour ambulatory blood pressure hypertension (daytime BP ≥135/85 mmHg OR nighttime BP ≥120/70 mmHg)

    Measured: 24-hour ambulatory blood pressure monitoring recording

  2. Prevalence of white-coat hypertension

    High office blood pressure (BP ≥140/90 mmHg) AND normal 24-hour ambulatory blood pressure (daytime BP <135/85 mmHg AND nighttime BP <120/70 mmHg)

    Measured: 24-hour ambulatory blood pressure monitoring recording

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2026
  2. Study start22 May 2023
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
316 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07740434
Sponsor's protocol ID
2022-A02249-34
Acronym
TRACA
Status last verified
Jul 2026
First submitted
28 Jul 2026
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Blood Pressure Monitoring, Ambulatory and Cardiovascular (CV) Risk, run by University of Burgundy at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claire ZABAWA, Dr (+33699835326, claire.zabawa@u-bourgogne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of masked hypertension (time frame: 24-hour ambulatory blood pressure monitoring recording). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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