Short Term Reproducibility of Office White-coat Effect

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Caen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

adult patients ;

not taking any antihypertensive medication;

free of any cardiovascular pathology.

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • blood pressure measurement

    Device

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

Treatment groups

922 Participants
are divided into 2 treatment groups
Group A: no reproducibility of OWCETOther 1 intervention
Group B: reproducibility of OWCETNo intervention 0 interventions

Trial outcomes

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).

Time frame
1 month

Secondary outcomes

1

Factors associated with reproducibility of OWCET

Patients characteristics

Time frame
1 month
2

Different definitions of OWCET

Variation of OWCET definition in order to test OWCET reproducibility

Time frame
1 month
3

blood pressure Variability

To test impact of blood pressure variability

Time frame
1 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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