White Coat HypertensionREBBRENCT06523062
Short Term Reproducibility of Office White-coat Effect
A study testing blood pressure measurement in people with White Coat Hypertension, run by University Hospital, Caen.
Trial summary
While a theoretical increase in systolic blood pressure (BP) of 10 mmHg can triple the relative risk of cardiovascular disease (CVD), the potential presence of a white coat effect (WCE) can interfere with the assessment of blood pressure control in the consultation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- White Coat Hypertension
- What is being tested?
- blood pressure measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 922 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients ;
- not taking any antihypertensive medication;
- free of any cardiovascular pathology.
Who cannot join
- patients who are minors or protected adults ;
- patients with BP ≥160/105 mmHg;
- history of secondary hypertension;
- taking a treatment that may affect blood pressure.
About this study
While a theoretical increase in systolic blood pressure (BP) of 10 mmHg can triple the relative risk of cardiovascular disease (CVD), the potential presence of a white coat effect (WCE) can interfere with the assessment of blood pressure control in the consultation. However, it is often difficult to assess the presence of a white coat effect (a quantitative variable) in general practice because of the difficulties in performing ambulatory BP measurements (self-measurement of blood pressure or ambulatory BP measurements). We have therefore previously described a surrogate concept of WCE obtained during a consultation with a general practitioner. It corresponds to a reduction of 10mmHg or more in systolic BP between the start and the end of the consultation. We have named it 'office white coat effect tail' (OWCET) and we have shown that OWCET, as a dichotomous variable, in a large Italian population cohort, with a follow-up of more than 18 years, was associated with an excess incidence of stroke, myocardial infarction (MI) and CVD and with excess mortality from MI and CVD. This concept appears to be more prevalent in women and is independent of blood pressure variability (regression to the mean). In addition, there is a genuine correlation between WCE and OWCET. To our knowledge, the reproducibility of the OWCET has never been studied, which could distort the relevance of this concept in the context of cardiovascular risk stratification in primary care.
- Conditions
- White Coat Hypertension
- Being tested
- blood pressure measurement
- Keywords
- white coat effect, reproducibility, primary care
- Medical subject headings
- White Coat Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood pressure measurementDevice
automated blood pressure measurement on 3 occasions at each consultation, twice with one month apart
| Study group | Role | What they receive |
|---|---|---|
| no reproducibility of OWCET | Other | Not described Receives: Device: blood pressure measurement |
| reproducibility of OWCET | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
OWCET
Measurement of OWCET on two occasions during two consultations separated by one month, using the same automated blood pressure monitor, in order to estimate an intraclass kappa coefficient (qualitative measurement).
Measured: 1 month
Secondary outcomes (3)
Factors associated with reproducibility of OWCET
Patients characteristics
Measured: 1 month
Different definitions of OWCET
Variation of OWCET definition in order to test OWCET reproducibility
Measured: 1 month
blood pressure Variability
To test impact of blood pressure variability
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Coat HypertensionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- cohort
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 922 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523062
- Sponsor's protocol ID
- 23-0196
- Acronym
- REBBRE
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An initial inclusion visit, followed by a further visit at 1 month, with automated blood pressure measurement on 3 occasions at each visit, one month apart. At the first consultation, useful data were collected (age, sex, tobacco, alcohol, BMI, history of diabetes, history of chronic kidney disease, history of ischaemic heart disease).
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Reproducibility of Office White-coat Effect
- ClinicalTrials.gov ID
- NCT06523062
- Acronym / sponsor ID
- REBBRE / 23-0196
- Conditions
- White Coat Hypertension
- Keywords
- white coat effect, reproducibility, primary care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 922 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While a theoretical increase in systolic blood pressure (BP) of 10 mmHg can triple the relative risk of cardiovascular disease (CVD), the potential presence of a white coat effect (WCE) can interfere with the assessment of blood pressure control in the consultation. However, it is often difficult to assess the presence of a white coat effect (a quantitative variable) in general practice because of the difficulties in performing ambulatory BP measurements (self-measurement of blood pressure or ambulatory BP measurements). We have therefore previously described a surrogate concept of WCE obtained during a consultation with a general practitioner. It corresponds to a reduction of 10mmHg or more in systolic BP between the start and the end of the consultation. We have named it 'office white coat effect tail' (OWCET) and we have shown that OWCET, as a dichotomous variable, in a large Italian population cohort, with a follow-up of more than 18 years, was associated with an excess incidence of stroke, myocardial infarction (MI) and CVD and with excess mortality from MI and CVD. This concept appears to be more prevalent in women and is independent of blood pressure variability (regression to the mean). In addition, there is a genuine correlation between WCE and OWCET. To our knowledge, the reproducibility of the OWCET has never been studied, which could distort the relevance of this concept in the context of cardiovascular risk stratification in primary care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- cohort
| Arm | Type | Receives |
|---|---|---|
| no reproducibility of OWCET | Other | Device: blood pressure measurement |
| reproducibility of OWCET | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients ;
- not taking any antihypertensive medication;
- free of any cardiovascular pathology.
Key exclusion criteria (4 listed)
- patients who are minors or protected adults ;
- patients with BP ≥160/105 mmHg;
- history of secondary hypertension;
- taking a treatment that may affect blood pressure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood pressure measurementautomated blood pressure measurement on 3 occasions at each consultation, twice with one month apart | Device | no reproducibility of OWCET |
Primary outcome
OWCET
Time frame: 1 month
Measurement of OWCET on two occasions during two consultations separated by one month, using the same automated blood pressure monitor, in order to estimate an intraclass kappa coefficient (qualitative measurement).
3 secondary outcomes
Factors associated with reproducibility of OWCET
Time frame: 1 month
Different definitions of OWCET
Time frame: 1 month
blood pressure Variability
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: Yes. An initial inclusion visit, followed by a further visit at 1 month, with automated blood pressure measurement on 3 occasions at each visit, one month apart. At the first consultation, useful data were collected (age, sex, tobacco, alcohol, BMI, history of diabetes, history of chronic kidney disease, history of ischaemic heart disease).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing blood pressure measurement in people with White Coat Hypertension, run by University Hospital, Caen.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OWCET (time frame: 1 month). 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 26 Jul 2024.