Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement

NCT ID: NCT03732924

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

618 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2020-07-15

Brief Summary

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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

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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

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Hypertension Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Five minute rest

Group Type EXPERIMENTAL

Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement

Intervention Type DIAGNOSTIC_TEST

To compare the difference between the daytime ABPM and AOBP with zero or five minutes wait time.

Zero minute rest

Group Type ACTIVE_COMPARATOR

Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement

Intervention Type DIAGNOSTIC_TEST

To compare the difference between the daytime ABPM and AOBP with zero or five minutes wait time.

Interventions

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Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement

To compare the difference between the daytime ABPM and AOBP with zero or five minutes wait time.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older
* Referred for ABPM
* Written informed consent

Exclusion Criteria

* Unable to perform AOBP or ABPM for some reason
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KMH Cardiology and Diagnostic Centres

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Sheldon Tobe

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheldon W Tobe, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Research Institute

Locations

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Sunnybrook & Women's College Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 34176286 (View on PubMed)

Other Identifiers

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181-2018

Identifier Type: -

Identifier Source: org_study_id

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