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

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ClinicalTrials.gov Identifier: NCT03360669
Recruitment Status : Completed
First Posted : December 4, 2017
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Maxime Lamarre-Cliche, Institut de Recherches Cliniques de Montreal

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.

Condition or disease Intervention/treatment Phase
Hypertension Other: Sequence: Clinical/Research Other: Sequence: Research/Clinical Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Blood Pressure Measurement With an Omron HEM-907 Device in a Clinical Setting and a Research Setting
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : March 29, 2018
Actual Study Completion Date : March 29, 2018

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

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




Primary Outcome Measures :
  1. Mean automated office blood pressure systolic blood pressure estimates [ Time Frame: Up to 2 weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360669


Locations
Canada, Quebec
Institut de Recherches Cliniques de Montréal
Montreal, Quebec, Canada, H2W1R7
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal

Publications:
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, Vallée 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, Côté AM, Woo V, Kaczorowski J, Trudeau L, Tsuyuki RT, Hiremath S, Drouin D, Lavoie KL, Hamet P, Grégoire 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.

Responsible Party: Maxime Lamarre-Cliche, MD, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT03360669     History of Changes
Other Study ID Numbers: OMRON HEM-907
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: according to specific scientifically pertinent demands
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maxime Lamarre-Cliche, Institut de Recherches Cliniques de Montreal:
hypertension, blood pressure, systolic, diastolic, AOBP, Omron HEM-907, research, clinical

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases