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Clinical Trials/NCT03267420
NCT03267420
Completed
Not Applicable

Blood Pressure Measurement: Should Technique Define Targets?

Ottawa Hospital Research Institute1 site in 1 country78 target enrollmentOctober 12, 2017
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Ottawa Hospital Research Institute
Enrollment
78
Locations
1
Primary Endpoint
Casual Blood Pressure versus Omron HEM 907XL unattended
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Hypertension is the single most important risk factor for cardiovascular disease and death, yet blood pressure itself is highly influenced by technique and device. Hence, the target blood pressure could vary materially based on BP technique and device used. In the present study, the investigators will compare 4 different methods of measuring blood pressure in the office (casual, resting average of 3 readings with nurse present or absent for resting period, and average of 5 readings) as well as a 24 hour ambulatory measurement. The results of this study will help and enable practicing family physicians and specialists in Canada to target BP for their patients based on algorithm and method of assessment of BP they use in their offices.

Detailed Description

Hypertension is the single most important risk factor for cardiovascular disease and death. Over the last several decades many classes of blood pressure lowering drugs have been discovered. These allow physicians to achieve optimal blood pressure and prevent adverse cardiovascular outcomes in most patients. However, the optimal blood pressure level has changed over time, and most recently has been decreased to 120 mm Hg, on the basis of clinical trials. These trials used a specific rigorous method of blood pressure measurement (patient alone in room, enforced period of rest, average of multiple readings) that is currently not the standard of practice in most clinics. Blood pressure itself is highly influenced by technique and device. In particular the length of resting time (if any), and whether it is measured with device requiring medical personnel presence in the room or not. For the same individual, the difference between blood pressure taken with and without rest could be 10 mmHg, and presence vs absence of medical personnel in the room during rest and/or BP assessment could be another 10 mmHg. Hence, the target blood pressure could vary materially based on BP technique and device used. As it is unlikely that all physicians can change their practice overnight and embrace blood pressure device allowing for standard resting time and unattended blood assessment, a comparative pragmatic study of the blood pressure technique and devices endorsed by Hypertension Canada and used in Canada is desirable to avoid either over- or under-treatment of Canadian patients with hypertension. In the present study, the investigators will compare 4 different methods of measuring blood pressure in the office (casual, resting average of 3 readings with nurse present or absent for resting period, and average of 5 readings) as well as a 24 hour ambulatory measurement in 90 patients. The results of this study will help and enable practicing family physicians and specialists in Canada to target BP for their patients based on algorithm and method of assessment of BP they use in their offices.

Registry
clinicaltrials.gov
Start Date
October 12, 2017
End Date
August 31, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All patients being followed in the Renal Hypertension Clinic will be eligible for enrollment

Exclusion Criteria

  • Inability to do oscillometric measures (eg., arrhythmia, pain, device reporting error)
  • inability to consent the patient

Outcomes

Primary Outcomes

Casual Blood Pressure versus Omron HEM 907XL unattended

Time Frame: 24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3)

The effect of unattended 5-minute rest preceding unattended systolic blood pressure assessment will be derived from the difference between casual blood pressure (measured in mm Hg) and average resting unattended systolic blood pressure (measured in mm Hg) as measured with the Omron HEM 907 XL

Secondary Outcomes

  • BpTRU versus Omron HEM 907XL with 5 minutes unattended rest(24 Hours: from Visit 1 and Visit 2 (from groups 1 and 2))
  • Omron HEM 907XL unattended versus Omron HEM 907XL partially attended(24 hours: from Visit 1 and Visit 2 (group 3))
  • Omron HEM 907XL unattended versus ABPM device(24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3))

Study Sites (1)

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