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Short Term Reproducibility of Office White-coat Effect

Short Term Reproducibility of Office White-coat Effect

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06523062
Acronym
REBBRE
Enrollment
922
Registered
2024-07-26
Start date
2024-09-01
Completion date
2025-08-31
Last updated
2024-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Coat Hypertension

Keywords

white coat effect, reproducibility, primary care

Brief 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. 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.

Interventions

DEVICEblood pressure measurement

automated blood pressure measurement on 3 occasions at each consultation, twice with one month apart

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Masking description

adults \> 18 y

Intervention model description

cohort

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* adult patients ; * not taking any antihypertensive medication; * free of any cardiovascular pathology.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
OWCET1 monthMeasurement 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).

Secondary

MeasureTime frameDescription
Factors associated with reproducibility of OWCET1 monthPatients characteristics
Different definitions of OWCET1 monthVariation of OWCET definition in order to test OWCET reproducibility
blood pressure Variability1 monthTo test impact of blood pressure variability

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026