Short Term Reproducibility of Office White-coat Effect

NCT ID: NCT06523062

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 922 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-08-31

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.

Conditions

White Coat Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

no reproducibility of OWCET

Group Type: OTHER

blood pressure measurement

Intervention Type: DEVICE

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

reproducibility of OWCET

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

blood pressure measurement

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

23-0196

Identifier Type: -

Identifier Source: org_study_id