NCT03732924

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
618

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

November 5, 2018

Last Update Submit

September 6, 2020

Conditions

HypertensionCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Difference in systolic and diastolic BP in patients randomized to zero or five minutes wait before the AOBP measurement.

    difference in blood pressure

    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.

    4 months - 1yr

Study Arms (2)

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

Interventions

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.

Five minute restZero minute rest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unable to perform AOBP or ABPM for some reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook & Women's College Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 34176286DERIVED

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

  • Sheldon W Tobe, MD

    Sunnybrook Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 7, 2018

Study Start

November 15, 2018

Primary Completion

February 15, 2020

Study Completion

July 15, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)