HypertensionOMRONHEM-907NCT03360669

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

A study testing Sequence: Clinical/Research and Sequence: Research/Clinical in people with Hypertension, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Sequence: Clinical/Research and Sequence: Research/Clinical
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteCanada
Study dates: 27 Nov 2017to 29 Mar 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

Institut de Recherches Cliniques de Montréal
Montreal, Quebec, H2W1R7

Other trials in Canada

About this study

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.

Conditions: Hypertension
Being tested: Sequence: Clinical/Research, Sequence: Research/Clinical
Keywords: hypertension, blood pressure, systolic, diastolic, AOBP, Omron HEM-907, research, clinical
Medical subject headings: Hypertension, Systolic Murmurs, Heart Murmurs

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sequence: Clinical/ResearchOther
Participants will be assigned to a sequence of: research visit first/clinical visit second.
Sequence: Research/ClinicalOther
Participants will be assigned to a sequence of: clinical visit first/research visit second.

Study groups in NCT03360669
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Sequence: Research/Clinical

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean automated office blood pressure systolic blood pressure estimates
Measured: Up to 2 weeks

Secondary outcomes (2)

Mean automated office blood pressure diastolic blood pressure estimates.
Measured: Up to 2 weeks
Individual unaveraged automated office systolic and diastolic blood pressure measurements (1, 2 and 3)
Measured: Up to 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Nov 201729 Mar 2018

First posted4 Dec 2017
Study start27 Nov 2017
Primary completion29 Mar 2018
Study completion29 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03360669
Sponsor's protocol ID: OMRON HEM-907
Acronym: OMRONHEM-907
Status last verified: Apr 2018
First submitted: 17 Nov 2017
Last updated: 11 Apr 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: according to specific scientifically pertinent demands

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.
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.
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Blood Pressure Measurement With an Omron HEM-907 Device in a Clinical Setting and a Research Setting
ClinicalTrials.gov ID: NCT03360669
Acronym / sponsor ID: OMRONHEM-907 / OMRON HEM-907
Conditions: Hypertension
Keywords: hypertension, blood pressure, systolic, diastolic, AOBP, Omron HEM-907, research, clinical
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Institut de Recherches Cliniques de MontrealUniversity, hospital or other
Study start: 27 Nov 2017 (actual)
Primary completion: 29 Mar 2018 (actual)
Study completion: 29 Mar 2018 (actual)
First posted: 4 Dec 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequence: Clinical/Research	Experimental	Other: Sequence: Clinical/ResearchParticipants 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.
Sequence: Research/Clinical	Active comparator	Other: Sequence: Research/ClinicalParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sequence: Clinical/ResearchParticipants will be assigned to a sequence of: research visit first/clinical visit second.	Other	Sequence: Clinical/Research
Sequence: Research/ClinicalParticipants will be assigned to a sequence of: clinical visit first/research visit second.	Other	Sequence: Research/Clinical

Primary outcome

Mean automated office blood pressure systolic blood pressure estimates
Time frame: Up to 2 weeks

2 secondary outcomes

Mean automated office blood pressure diastolic blood pressure estimates.
Time frame: Up to 2 weeks
Individual unaveraged automated office systolic and diastolic blood pressure measurements (1, 2 and 3)
Time frame: Up to 2 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
Background: PubMed 26711315Padwal 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.
Background: PubMed 8622248Kannel WB. Blood pressure as a cardiovascular risk factor: prevention and treatment. JAMA. 1996 May 22-29;275(20):1571-6.
Background: PubMed 26724178Ettehad 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.
Background: PubMed 3336140Pickering 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.
Background: PubMed 12799100Myers 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.
Background: PubMed 23969286Edwards 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.
Background: PubMed 28449828Leung 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.
Background: PubMed 26551272SPRINT 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.
Background: PubMed 21300709Myers 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.
Background: PubMed 7662244Myers 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.
Background: PubMed 19417634Myers 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.
Background: PubMed 28159816Agarwal 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.
Individual participant dataSharing planned: Yes. according to specific scientifically pertinent demands

Related trials for Hypertension

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sequence: Clinical/Research and Sequence: Research/Clinical in people with Hypertension, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean automated office blood pressure systolic blood pressure estimates (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03360669, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.