Clinical trial NCT03360669: Comparison of Blood Pressure Measurement With an Omron HEM-907 Device in a Clinical Setting and a Research Setting
Official title: Comparison of Blood Pressure Measurement With an Omron HEM-907 Device in a Clinical Setting and a Research Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension, blood pressure, systolic, diastolic, AOBP, Omron HEM-907, research, clinical
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Automated office blood pressure (AOBP) devices are recommended for high blood pressure diagnosis. One of those devices is the Omron HEM-907 (Omron Healthcare). It is currently not known if blood pressure measurements performed with this device in a clinical setting are equivalent to those made in a research setting. Therefore, this randomized-controlled trial was designed. It aims to compare the blood pressure measurements performed in a clinical and a research setting. Seventy patients will be included and randomized to a clinical/research or research/clinical sequence.

Detailed description: Hypertension is a common condition, with an estimated prevalence around 20 percent in Canada. It is a major risk factor for cardiovascular disease. Recently, Hypertension Canada has updated its guidelines and recommend we should consider a 120 mm Hg systolic blood pressure target in high-risk patients aged 50 years or older. This recommendation derives mainly from the SPRINT trial. In this trial, blood pressure was measured with an automated oscillometric blood pressure (AOBP) device, the Omron HEM-907 (Omron Healthcare). However, it is not known if measurements performed with this device in a clinical setting are equivalent to those made in a research setting. Therefore, this randomized-controlled trial was designed. It aims to compare the blood pressure measurements of 70 patients in a clinical and a research setting. Patients will be randomized to a clinical/research or a research/clinical sequence.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Hypertensive or presumed hypertensive
* Patients with a scheduled visit at the IRCM hypertension clinic.

Exclusion Criteria:

* Limitation preventing the measurement of blood pressure
* Introduction or withdrawal of any blood pressure-modifying medication starting 4 weeks before the first and until the last study visit.
* Recreative drug use (except cannabis)
* Alcohol use of more than 4 drinks during the day
* New symptoms during the research visit, that warrants a medical evaluation
* Mean systolic blood pressure \>180 mm Hg or mean diastolic blood pressure \>110 mm Hg (using AOBP)

Primary outcomes:
measure: Mean automated office blood pressure systolic blood pressure estimates
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Mean automated office blood pressure diastolic blood pressure estimates.
timeFrame: Up to 2 weeks
measure: Individual unaveraged automated office systolic and diastolic blood pressure measurements (1, 2 and 3)
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Institut de Recherches Cliniques de Montréal
state: Quebec
Study officials:
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