Comparison of Blood Pressure Measurement With an Omron HEM-907 Device in a Clinical Setting and a Research Setting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Blood Pressure Measurement With an Omron HEM-907 Device in a Clinical Setting and a Research Setting

Conditions
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Hypertension

Intervention / Treatment
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* Other: Sequence: Clinical/Research
* Other: Sequence: Research/Clinical


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence: Clinical/Research<br>Participants assigned to this arm will have their blood pressure measured in a clinical setting first, and in a research setting second. The sequence randomization corresponds to the intervention. Visits will be at least a day apart but within a two-week period. During the clinical visit, they will have their blood pressure measured with the Omron HEM-907, an automated office blood pressure (AOBP) device. During the research setting, participants will be guided through a series of research-driven steps such as study questionnaires and completion of consent forms. They will have their blood pressure measured in both arms with a mercury sphygmomanometer, and then 3 measurements with a mercury sphygmomanometer. AOBP measurements (Omron HEM-907) will be performed at the end of the visit. | Other: Sequence: Clinical/Research<br>* Participants will be assigned to a sequence of: research visit first/clinical visit second.<br>|
| Active Comparator: Sequence: Research/Clinical<br>Participants assigned to this arm will go through the same measurements and procedures exception made of the research-first and clinical-second sequence. The intervention to which they are randomized corresponds to the sequence of the visits. | Other: Sequence: Research/Clinical<br>* Participants will be assigned to a sequence of: clinical visit first/research visit second.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean automated office blood pressure systolic blood pressure estimates |  | Up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, blood pressure, systolic, diastolic, AOBP, Omron HEM-907, research, clinical