Blood Pressure Measurement: Should Technique Define Targets?

NCT03267420 | Completed

• 1 other identifier: 6486
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

  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

  24 Hours: from Visit 1 and Visit 2 (from groups 1 and 2)

• Omron HEM 907XL unattended versus Omron HEM 907XL partially attended

  24 hours: from Visit 1 and Visit 2 (group 3)

• Omron HEM 907XL unattended versus ABPM device

  24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3)

Study Arms (3)

Group 1

EXPERIMENTAL

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

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.

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.

Diagnostic Test: Partially Attended Omron First, Unattended Omron Second

Interventions

BpTRU First, Unattended Omron Second DIAGNOSTIC_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.

Group 1

Unattended Omron First, BpTRU Second DIAGNOSTIC_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.

Group 2

Partially Attended Omron First, Unattended Omron Second DIAGNOSTIC_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.

Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients being followed in the Renal Hypertension Clinic will be eligible for enrollment

You may not qualify if:

• Inability to do oscillometric measures (eg., arrhythmia, pain, device reporting error)
• inability to consent the patient

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

The Hypertension Unit of The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marcel Ruzicka, MD, PHD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: August 30, 2017
• Study Start: October 12, 2017
• Primary Completion: June 30, 2019
• Study Completion: August 31, 2019
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)