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

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 Overview

• Status: Not yet recruiting
• Conditions: White Coat Hypertension
• Intervention / Treatment: Device: blood pressure measurement

• Study Type: Interventional
• Enrollment (Estimated): 922
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: no reproducibility of OWCET	Device: blood pressure measurement; automated blood pressure measurement on 3 occasions at each consultation, twice with one month apart
No Intervention: reproducibility of OWCET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors associated with reproducibility of OWCET	Patients characteristics	1 month
Different definitions of OWCET	Variation of OWCET definition in order to test OWCET reproducibility	1 month
blood pressure Variability	To test impact of blood pressure variability	1 month

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: primary care; reproducibility; white coat effect
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; White Coat Hypertension
• Other Study ID Numbers: 23-0196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No