HypertensionNCT03267420
Blood Pressure Measurement: Should Technique Define Targets?
A study testing BpTRU First, Unattended Omron Second, Unattended Omron First, BpTRU Second and Partially Attended Omron First, Unattended Omron Second in people with Hypertension, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- BpTRU First, Unattended Omron Second, Unattended Omron First, BpTRU Second and Partially Attended Omron First, Unattended Omron Second
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- 12 Oct 2017to 31 Aug 2019
- 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
- All patients being followed in the Renal Hypertension Clinic will be eligible for enrollment
Who cannot join
- Inability to do oscillometric measures (eg., arrhythmia, pain, device reporting error)
- inability to consent the patient
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Hypertension Unit of The Ottawa Hospital
Ottawa, Ontario, K1H 7W9
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- BpTRU First, Unattended Omron Second, Unattended Omron First, BpTRU Second, Partially Attended Omron First, Unattended Omron Second
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BpTRU First, Unattended Omron SecondDiagnostic test
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.
Unattended Omron First, BpTRU SecondDiagnostic test
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.
Partially Attended Omron First, Unattended Omron SecondDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | A group of 30 randomly assigned study participants that will undergo the BpTRU First, Unattended Omron Second exposure. Receives: Diagnostic Test: BpTRU First, Unattended Omron Second |
| Group 2 | Active comparator | A group of 30 randomly assigned study participants that will undergo the Unattended Omron First, BpTRU Second exposure. Receives: Diagnostic Test: Unattended Omron First, BpTRU Second |
| Group 3 | Active comparator | A group of 30 randomly assigned study participants that will undergo the Partially Attended Omron First, Unattended Omron Second exposure. Receives: Diagnostic Test: Partially Attended Omron First, Unattended Omron Second |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3)
Secondary outcomes (3)
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
Measured: 24 Hours: from Visit 1 and Visit 2 (from groups 1 and 2)
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)
Measured: 24 hours: from Visit 1 and Visit 2 (group 3)
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
Measured: 24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start12 Oct 2017
- Primary completion30 Jun 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Marcel Ruzicka, MD, PHD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267420
- Sponsor's protocol ID
- 6486
- Status last verified
- Mar 2021
- First submitted
- 20 Jul 2017
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Measurement: Should Technique Define Targets?
- ClinicalTrials.gov ID
- NCT03267420
- Acronym / sponsor ID
- 6486
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 30 Aug 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Diagnostic Test: BpTRU First, Unattended Omron SecondA group of 30 randomly assigned study participants that will undergo the BpTRU First, Unattended Omron Second exposure. |
| Group 2 | Active comparator | Diagnostic Test: Unattended Omron First, BpTRU SecondA group of 30 randomly assigned study participants that will undergo the Unattended Omron First, BpTRU Second exposure. |
| Group 3 | Active comparator | Diagnostic Test: Partially Attended Omron First, Unattended Omron SecondA group of 30 randomly assigned study participants that will undergo the Partially Attended Omron First, Unattended Omron Second exposure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients being followed in the Renal Hypertension Clinic will be eligible for enrollment
Key exclusion criteria (2 listed)
- Inability to do oscillometric measures (eg., arrhythmia, pain, device reporting error)
- inability to consent the patient
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 |
|---|---|---|
| BpTRU First, Unattended Omron SecondVisit 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. | Diagnostic test | Group 1 |
| Unattended Omron First, BpTRU SecondVisit 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. | Diagnostic test | Group 2 |
| Partially Attended Omron First, Unattended Omron SecondVisit 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. | Diagnostic test | Group 3 |
Primary outcome
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
3 secondary outcomes
BpTRU versus Omron HEM 907XL with 5 minutes unattended rest
Time frame: 24 Hours: from Visit 1 and Visit 2 (from groups 1 and 2)
Omron HEM 907XL unattended versus Omron HEM 907XL partially attended
Time frame: 24 hours: from Visit 1 and Visit 2 (group 3)
Omron HEM 907XL unattended versus ABPM device
Time frame: 24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3)
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 3 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Marcel Ruzicka, MD, PHD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BpTRU First, Unattended Omron Second, Unattended Omron First, BpTRU Second and Partially Attended Omron First, Unattended Omron Second in people with Hypertension, run by Ottawa Hospital Research Institute 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 1 inclusion and 2 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 3 Mar 2021. 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?
Casual Blood Pressure versus Omron HEM 907XL unattended (time frame: 24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2021.