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NCT Number: NCT06523062

Short Term Reproducibility of Office White-coat Effect

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Pressure Measurement

Device

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

Primary outcomes

  1. OWCET

    Time frame: 1 month

    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).

Secondary outcomes

  1. Factors associated with reproducibility of OWCET

    Time frame: 1 month

    Patients characteristics

  2. Different definitions of OWCET

    Time frame: 1 month

    Variation of OWCET definition in order to test OWCET reproducibility

  3. blood pressure Variability

    Time frame: 1 month

    To test impact of blood pressure variability

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: REBBRE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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