Hypertension
Conditions
Keywords
hypertension, blood pressure, systolic, diastolic, AOBP, Omron HEM-907, research, clinical
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.
Interventions
OTHERSequence: Research/Clinical
Participants will be assigned to a sequence of: clinical visit first/research visit second.
OTHERSequence: Clinical/Research
Participants will be assigned to a sequence of: research visit first/clinical visit second.
Sponsors
Institut de Recherches Cliniques de Montreal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean automated office blood pressure systolic blood pressure estimates | Up to 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mean automated office blood pressure diastolic blood pressure estimates. | Up to 2 weeks |
| Individual unaveraged automated office systolic and diastolic blood pressure measurements (1, 2 and 3) | Up to 2 weeks |
Countries
Canada
Outcome results
None listed