HypertensionNCT03732924
Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement
A study testing Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement in people with Hypertension and Cardiovascular Diseases, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The Hypertension Canada Clinical Practice Guidelines for blood pressure measurement using AOBP recommend against any wait time prior to commencing the measurement. The recent AHA guidelines however call for a 5-minute rest first. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Cardiovascular Diseases
- What is being tested?
- Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 618 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2018to 15 Jul 2020
- 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
- Age 18 years or older
- Referred for ABPM
- Written informed consent
Who cannot join
- Unable to perform AOBP or ABPM for some reason
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement: the Impact of a 5 Minute Rest Time on AOBP Measurement
The Hypertension Canada Clinical Practice Guidelines for blood pressure measurement using AOBP recommend against any wait time prior to commencing the measurement. The recent AHA guidelines however call for a 5-minute rest first. In uncontrolled hypertension, AOBP is typically higher than the daytime readings from ambulatory blood pressure monitoring (ABPM), but this is not the case for patients with controlled hypertension.
Read the detailed description
Objective:
Does a 5 minute rest or no rest before measurement using AOBP provide the most accurate reading in patients with controlled and uncontrolled hypertension, and in patients with white coat hypertension compared to daytime ABPM?
Implications:
Through this study, we hope to:
(i) Advance the understanding of the role of AOBP in measuring blood pressure. (ii) Determine whether a 5-minute rest, or no rest at all is needed prior to AOBP measurement.
(iii) Assess the relationship of AOBP to daytime ABPM for patient with controlled and uncontrolled hypertension and in patients with white coat hypertension.
- Conditions
- Hypertension, Cardiovascular Diseases
- Being tested
- Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) MeasurementDiagnostic test
To compare the difference between the daytime ABPM and AOBP with zero or five minutes wait time.
| Study group | Role | What they receive |
|---|---|---|
| Five minute rest | Experimental | Not described Receives: Diagnostic Test: Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement |
| Zero minute rest | Active comparator | Not described Receives: Diagnostic Test: Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in systolic and diastolic BP in patients randomized to zero or five minutes wait before the AOBP measurement.
difference in blood pressure
Measured: 4 months - 1 yr
Secondary outcomes (1)
Difference in systolic and diastolic BP between the AOBP and daytime ABPM in patients randomized to zero or five minutes wait before the AOBP measurement.
difference in blood pressure
Measured: 4 months - 1yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start15 Nov 2018
- Primary completion15 Feb 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 618 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- KMH Cardiology and Diagnostic Centres
- Responsible party
- Principal investigator, Sheldon Tobe, Sunnybrook Health Sciences Centre
- Investigators
- Sheldon W Tobe, MD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732924
- Sponsor's protocol ID
- 181-2018
- Status last verified
- Sep 2020
- First submitted
- 5 Nov 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tobe SW, Dubrofsky L, Nasser DI, Rajasingham R, Myers MG. Randomized Controlled Trial Comparing Automated Office Blood Pressure Readings After Zero or Five Minutes of Rest. Hypertension. 2021 Aug;78(2):353-359. doi: 10.1161/HYPERTENSIONAHA.121.17319. Epub 2021 Jun 28.
PubMed 34176286
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement: the Impact of a 5 Minute Rest Time on AOBP Measurement
- ClinicalTrials.gov ID
- NCT03732924
- Acronym / sponsor ID
- 181-2018
- Conditions
- Hypertension, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 618 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- KMH Cardiology and Diagnostic Centres
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 7 Nov 2018 (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.
The Hypertension Canada Clinical Practice Guidelines for blood pressure measurement using AOBP recommend against any wait time prior to commencing the measurement. The recent AHA guidelines however call for a 5-minute rest first. In uncontrolled hypertension, AOBP is typically higher than the daytime readings from ambulatory blood pressure monitoring (ABPM), but this is not the case for patients with controlled hypertension.
Detailed description
Objective:
Does a 5 minute rest or no rest before measurement using AOBP provide the most accurate reading in patients with controlled and uncontrolled hypertension, and in patients with white coat hypertension compared to daytime ABPM?
Implications:
Through this study, we hope to:
(i) Advance the understanding of the role of AOBP in measuring blood pressure. (ii) Determine whether a 5-minute rest, or no rest at all is needed prior to AOBP measurement.
(iii) Assess the relationship of AOBP to daytime ABPM for patient with controlled and uncontrolled hypertension and in patients with white coat hypertension.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Five minute rest | Experimental | Diagnostic Test: Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement |
| Zero minute rest | Active comparator | Diagnostic Test: Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Referred for ABPM
- Written informed consent
Key exclusion criteria (1 listed)
- Unable to perform AOBP or ABPM for some reason
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 |
|---|---|---|
| Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) MeasurementTo compare the difference between the daytime ABPM and AOBP with zero or five minutes wait time. | Diagnostic test | Five minute rest, Zero minute rest |
Primary outcome
Difference in systolic and diastolic BP in patients randomized to zero or five minutes wait before the AOBP measurement.
Time frame: 4 months - 1 yr
difference in blood pressure
1 secondary outcome
Difference in systolic and diastolic BP between the AOBP and daytime ABPM in patients randomized to zero or five minutes wait before the AOBP measurement.
Time frame: 4 months - 1yr
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 9 Sep 2020.
- Derived from this study: PubMed 34176286Tobe SW, Dubrofsky L, Nasser DI, Rajasingham R, Myers MG. Randomized Controlled Trial Comparing Automated Office Blood Pressure Readings After Zero or Five Minutes of Rest. Hypertension. 2021 Aug;78(2):353-359. doi: 10.1161/HYPERTENSIONAHA.121.17319. Epub 2021 Jun 28.
- 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.
Sheldon W Tobe, MD principal investigator
Sunnybrook 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 Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement in people with Hypertension and Cardiovascular Diseases, run by Sunnybrook Health Sciences Centre 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 1 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 9 Sep 2020. 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?
Difference in systolic and diastolic BP in patients randomized to zero or five minutes wait before the AOBP measurement. (time frame: 4 months - 1 yr). 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 NCT03732924, which also lists 1 linked publication.
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 9 Sep 2020.