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Blood Pressure Measurement: Should Technique Define Targets?

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
BpTRU First, Unattended Omron Second
Unattended Omron First, BpTRU Second
Partially Attended Omron First, Unattended Omron Second
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hypertension Unit of The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

A group of 30 randomly assigned study participants that will undergo the BpTRU First, Unattended Omron Second exposure.

A group of 30 randomly assigned study participants that will undergo the Unattended Omron First, BpTRU Second exposure.

A group of 30 randomly assigned study participants that will undergo the Partially Attended Omron First, Unattended Omron Second exposure.

Outcomes

Primary Outcome Measures

Casual Blood Pressure versus Omron HEM 907XL unattended
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 Outcome Measures

BpTRU versus Omron HEM 907XL with 5 minutes unattended rest
The difference between average systolic blood pressure measured with BpTRU and Omron HEM907XL (both measured in mm Hg) will allow us to report the effect of the additional five minutes of rest
Omron HEM 907XL unattended versus Omron HEM 907XL partially attended
Difference between systolic blood pressure between the two visits in Group 3 will address an issue of unattended versus partially attended resting systolic blood pressure (both measured in mm Hg)
Omron HEM 907XL unattended versus ABPM device
Difference between the average unattended systolic blood pressure and daytime average blood pressure from the 24 hour ABPM

Full Information

First Posted
July 20, 2017
Last Updated
March 2, 2021
Sponsor
Ottawa Hospital Research Institute
Collaborators
The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03267420
Brief Title
Blood Pressure Measurement: Should Technique Define Targets?
Official Title
Blood Pressure Measurement: Should Technique Define Targets?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
The Physicians' Services Incorporated Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
A group of 30 randomly assigned study participants that will undergo the BpTRU First, Unattended Omron Second exposure.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
A group of 30 randomly assigned study participants that will undergo the Unattended Omron First, BpTRU Second exposure.
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
A group of 30 randomly assigned study participants that will undergo the Partially Attended Omron First, Unattended Omron Second exposure.
Intervention Type
Diagnostic Test
Intervention Name(s)
BpTRU First, Unattended Omron Second
Intervention Description
Visit 1: The participants will have the oscillometric device, BpTRU applied to their arm with the higher blood pressure. This will allow assessment with the commonest used Canadian device, which provides an average after 5 unattended readings. This assessment will be followed by the participant wearing a 24 hour ambulatory blood pressure monitor (ABPM) for 24 hours. Visit 2: Upon returning the 24 hour ABPM device, the patient will have their blood pressure measured with an unattended Omron second. The Omron HEM 907XL will be applied to the same arm that the BpTRU was applied to in the first visit. There will be 5 minutes of quiet rest (participant alone) and three readings subsequently while the patient is still alone with the average blood pressure measurement being noted.
Intervention Type
Diagnostic Test
Intervention Name(s)
Unattended Omron First, BpTRU Second
Intervention Description
Visit 1: The participants will have the Omron HEM 907XL will be applied to their arm with the higher blood pressure. There will be 5 minutes of quiet rest (participant alone) and three readings subsequently while the patient is still alone with the average blood pressure measurement being noted.This assessment will be followed by the participant wearing a 24 hour ambulatory blood pressure monitor (ABPM) for 24 hours. Visit 2: Upon returning the 24 hour ABPM device, the participants will have the oscillometric device, BpTRU applied to the same arm that the Omron HEM 907 XL was applied to in the first visit. This will allow assessment with the commonest used Canadian device, which provides an average after 5 unattended blood pressure readings.
Intervention Type
Diagnostic Test
Intervention Name(s)
Partially Attended Omron First, Unattended Omron Second
Intervention Description
Visit 1: The participant will have the Omron HEM 907 XL applied to the arm with the higher blood pressure. There will be five minutes of quiet rest (patient alone) and three reading subsequently, but with the nurse entering the room (i.e., partially attended), with the average being noted. This assessment will be followed by the participant wearing a 24 hour ambulatory blood pressure monitor (ABPM) for 24 hours. Visit 2: Upon returning 24 hour ABPM device, the participant will have the Omron HEM 907 XL applied to same arm that was used during the first visit. There will be five minutes of quiet rest (patient alone) and three readings subsequently (patient still alone) with the average blood pressure measurement being noted.
Primary Outcome Measure Information:
Title
Casual Blood Pressure versus Omron HEM 907XL unattended
Description
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
Time Frame
24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3)
Secondary Outcome Measure Information:
Title
BpTRU versus Omron HEM 907XL with 5 minutes unattended rest
Description
The difference between average systolic blood pressure measured with BpTRU and Omron HEM907XL (both measured in mm Hg) will allow us to report the effect of the additional five minutes of rest
Time Frame
24 Hours: from Visit 1 and Visit 2 (from groups 1 and 2)
Title
Omron HEM 907XL unattended versus Omron HEM 907XL partially attended
Description
Difference between systolic blood pressure between the two visits in Group 3 will address an issue of unattended versus partially attended resting systolic blood pressure (both measured in mm Hg)
Time Frame
24 hours: from Visit 1 and Visit 2 (group 3)
Title
Omron HEM 907XL unattended versus ABPM device
Description
Difference between the average unattended systolic blood pressure and daytime average blood pressure from the 24 hour ABPM
Time Frame
24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcel Ruzicka, MD, PHD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hypertension Unit of The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Blood Pressure Measurement: Should Technique Define Targets?

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