Short Term Reproducibility of Office White-coat Effect

NCT06523062 | Not Yet Recruiting

• 1 other identifier: 23-0196
• Study Type: interventional
• Target: 922
• Locations: 0 countries
• Sites: N/A

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

Keywords

white coat effect; reproducibility; primary care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Factors associated with reproducibility of OWCET

  1 month

• Different definitions of OWCET

  1 month

• blood pressure Variability

  1 month

Study Arms (2)

no reproducibility of OWCET

OTHER

Device: blood pressure measurement

reproducibility of OWCET

NO INTERVENTION

Interventions

blood pressure measurement DEVICE

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

no reproducibility of OWCET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead

MeSH Terms

Conditions

White Coat Hypertension

Interventions

Blood Pressure Determination

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: adults \> 18 y
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cohort

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: September 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL