Short Term Reproducibility of Office White-coat Effect (REBBRE)

Caen University Hospital

Status: Not yet enrolling

Conditions: White Coat Hypertension

Treatments: Device: blood pressure measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT06523062

23-0196

Details and patient eligibility

About

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.

Enrollment: 922 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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922 participants in 2 patient groups

no reproducibility of OWCET

Other group

Treatment:

Device: blood pressure measurement

reproducibility of OWCET

No Intervention group