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

NCT03360669 | Completed

• 1 other identifier: OMRON HEM-907
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

hypertension, blood pressure, systolic, diastolic, AOBP, Omron HEM-907, research, clinical

Outcome Measures

Primary Outcomes (1)

• Mean automated office blood pressure systolic blood pressure estimates

  Up to 2 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

Sequence: Clinical/Research

EXPERIMENTAL

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

Sequence: Research/Clinical

ACTIVE COMPARATOR

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

Interventions

Sequence: Clinical/Research OTHER

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

Sequence: Clinical/Research

Sequence: Research/Clinical OTHER

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

Sequence: Research/Clinical

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Institut de Recherches Cliniques de Montréal

Montreal, Quebec, H2W1R7, Canada

Location

Related Publications (12)

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  PMID: 28449828 BACKGROUND

• SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9.

  PMID: 26551272 BACKGROUND

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MeSH Terms

Conditions

Hypertension; Systolic Murmurs; Heart Murmurs

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: December 4, 2017
• Study Start: November 27, 2017
• Primary Completion: March 29, 2018
• Study Completion: March 29, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)