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CompletedNCT03360669OMRONHEM-907Updated Apr 11, 2018

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

An interventional study of Sequence: Clinical/Research and Sequence: Research/Clinical in Hypertension, sponsored by Institut de Recherches Cliniques de Montreal. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-11.

Sponsored by Institut de Recherches Cliniques de Montreal · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 286 studies in Hypertension with a site in Canada — 27 open to participants now, 38 under way, 7 of them phase 3. Hypertension · Canada.

Enrollment
167th of 241
70 · median 169
Started
2017
with 8 others
No phase
118 of 286
13 open now
Registered
188th of 286
by date

Among the 286 studies in Hypertension with a site in Canada, this one is the 167th largest by enrollment of the 241 interventional ones, is one of 9 that started in 2017, is one of 118 with no phase, and was the 188th registered.

By phase

286 studies; the count open now beside each. This study's row is marked.

No phasethis study118 · 13 open
Phase 358 · 5 open
Observational45 · 5 open
Phase 424 · 1 open
Phase 223 · 0 open
Phase 112 · 3 open
Phase 2/34 · 0 open
Phase 1/22 · 0 open

By the year they started

First in 1999; this study’s year is marked. 9 started in 2017.

Size and results

Median enrollment 169 across the 241 interventional studies, 60 across the 45 observational. Of the 210 that completed or were terminated, 52 (25%) have results posted.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Hypertension

Keywords

  • hypertension, blood pressure, systolic, diastolic, AOBP, Omron HEM-907, research, clinical
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Sequence: Clinical/Research

    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

  • Active comparator
    Sequence: Research/Clinical

    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

  • OtherSequence: Clinical/Research

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

  • OtherSequence: Research/Clinical

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

06

What researchers measure

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

07

Study locations

1 site
  • Institut de Recherches Cliniques de Montréal
    Montreal, Quebec H2W1R7, Canada
08

References and documents

Publications

  • Padwal RS, Bienek A, McAlister FA, Campbell NR; Outcomes Research Task Force of the Canadian Hypertension Education Program. Epidemiology of Hypertension in Canada: An Update. Can J Cardiol. 2016 May;32(5):687-94. doi: 10.1016/j.cjca.2015.07.734. Epub 2015 Aug 15. PubMed 26711315 ↗
  • Kannel WB. Blood pressure as a cardiovascular risk factor: prevention and treatment. JAMA. 1996 May 22-29;275(20):1571-6. PubMed 8622248 ↗
  • Ettehad D, Emdin CA, Kiran A, Anderson SG, Callender T, Emberson J, Chalmers J, Rodgers A, Rahimi K. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet. 2016 Mar 5;387(10022):957-967. doi: 10.1016/S0140-6736(15)01225-8. Epub 2015 Dec 24. PubMed 26724178 ↗
  • Pickering TG, James GD, Boddie C, Harshfield GA, Blank S, Laragh JH. How common is white coat hypertension? JAMA. 1988 Jan 8;259(2):225-8. PubMed 3336140 ↗
  • Myers MG, Valdivieso MA. Use of an automated blood pressure recording device, the BpTRU, to reduce the "white coat effect" in routine practice. Am J Hypertens. 2003 Jun;16(6):494-7. doi: 10.1016/s0895-7061(03)00058-x. PubMed 12799100 ↗
  • Edwards C, Hiremath S, Gupta A, McCormick BB, Ruzicka M. BpTRUth: do automated blood pressure monitors outperform mercury? J Am Soc Hypertens. 2013 Nov-Dec;7(6):448-53. doi: 10.1016/j.jash.2013.07.002. Epub 2013 Aug 19. PubMed 23969286 ↗
  • Leung AA, Daskalopoulou SS, Dasgupta K, McBrien K, Butalia S, Zarnke KB, Nerenberg K, Harris KC, Nakhla M, Cloutier L, Gelfer M, Lamarre-Cliche M, Milot A, Bolli P, Tremblay G, McLean D, Tran KC, Tobe SW, Ruzicka M, Burns KD, Vallee M, Prasad GVR, Gryn SE, Feldman RD, Selby P, Pipe A, Schiffrin EL, McFarlane PA, Oh P, Hegele RA, Khara M, Wilson TW, Penner SB, Burgess E, Sivapalan P, Herman RJ, Bacon SL, Rabkin SW, Gilbert RE, Campbell TS, Grover S, Honos G, Lindsay P, Hill MD, Coutts SB, Gubitz G, Campbell NRC, Moe GW, Howlett JG, Boulanger JM, Prebtani A, Kline G, Leiter LA, Jones C, Cote AM, Woo V, Kaczorowski J, Trudeau L, Tsuyuki RT, Hiremath S, Drouin D, Lavoie KL, Hamet P, Gregoire JC, Lewanczuk R, Dresser GK, Sharma M, Reid D, Lear SA, Moullec G, Gupta M, Magee LA, Logan AG, Dionne J, Fournier A, Benoit G, Feber J, Poirier L, Padwal RS, Rabi DM; Hypertension Canada. Hypertension Canada's 2017 Guidelines for Diagnosis, Risk Assessment, Prevention, and Treatment of Hypertension in Adults. Can J Cardiol. 2017 May;33(5):557-576. doi: 10.1016/j.cjca.2017.03.005. Epub 2017 Mar 10. Erratum In: Can J Cardiol. 2017 Dec;33(12):1733-1734. doi: 10.1016/j.cjca.2017.09.006. PubMed 28449828 ↗
  • 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. Erratum In: N Engl J Med. 2017 Dec 21;377(25):2506. doi: 10.1056/NEJMx170008. PubMed 26551272 ↗
  • Myers MG, Godwin M, Dawes M, Kiss A, Tobe SW, Grant FC, Kaczorowski J. Conventional versus automated measurement of blood pressure in primary care patients with systolic hypertension: randomised parallel design controlled trial. BMJ. 2011 Feb 7;342:d286. doi: 10.1136/bmj.d286. PubMed 21300709 ↗
  • Myers MG, Oh PI, Reeves RA, Joyner CD. Prevalence of white coat effect in treated hypertensive patients in the community. Am J Hypertens. 1995 Jun;8(6):591-7. doi: 10.1016/0895-7061(95)00049-U. PubMed 7662244 ↗
  • Myers MG, Valdivieso M, Kiss A. Consistent relationship between automated office blood pressure recorded in different settings. Blood Press Monit. 2009 Jun;14(3):108-11. doi: 10.1097/MBP.0b013e32832c5167. PubMed 19417634 ↗
  • Agarwal R. Implications of Blood Pressure Measurement Technique for Implementation of Systolic Blood Pressure Intervention Trial (SPRINT). J Am Heart Assoc. 2017 Feb 3;6(2):e004536. doi: 10.1161/JAHA.116.004536. PubMed 28159816 ↗

Individual participant data

Plan to share: Yes — according to specific scientifically pertinent demands

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Mar 2018, 4 months.

Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 4 months is below that.

Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2017
First posted
Dec 4, 2017
StartActual
Nov 27, 2017
Primary completionActual
Mar 29, 2018
CompletionActual
Mar 29, 2018
Last update
Apr 11, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03360669
Lead sponsor
Institut de Recherches Cliniques de Montreal
Responsible party
Maxime Lamarre-Cliche (MD, Institut de Recherches Cliniques de Montreal) — Principal investigator
First posted
Dec 4, 2017
Start date
Nov 27, 2017
Primary completion
Mar 29, 2018
Completion
Mar 29, 2018
Last update
Apr 11, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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