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OpenTrials
Completed

NCT Number: NCT03360669

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Recherches Cliniques de Montréal

Montreal, Quebec, H2W1R7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sequence: Clinical/Research

Other

Participants will be assigned to a sequence of: research visit first/clinical visit second.

Sequence: Research/Clinical

Other

Participants will be assigned to a sequence of: clinical visit first/research visit second.

Primary outcomes

  1. Mean automated office blood pressure systolic blood pressure estimates

    Time frame: Up to 2 weeks

Secondary outcomes

  1. Mean automated office blood pressure diastolic blood pressure estimates.

    Time frame: Up to 2 weeks

  2. Individual unaveraged automated office systolic and diastolic blood pressure measurements (1, 2 and 3)

    Time frame: Up to 2 weeks

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Registry information

Acronym: OMRONHEM-907

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 4, 2017
Registry last updated
Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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