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 volunteersQualifiers
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
Single group
Treatments tested in this trial
blood pressure measurement
Deviceautomated blood pressure measurement on 3 occasions at each consultation, twice with one month apart
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
Factors associated with reproducibility of OWCET
Patients characteristics
Different definitions of OWCET
Variation of OWCET definition in order to test OWCET reproducibility
blood pressure Variability
To test impact of blood pressure variability
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: