Clinical trial NCT03267420: Blood Pressure Measurement: Should Technique Define Targets?
Official title: Blood Pressure Measurement: Should Technique Define Targets?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2017-08-30
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Casual Blood Pressure versus Omron HEM 907XL unattended
timeFrame: 24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3)
Secondary outcomes:
measure: BpTRU versus Omron HEM 907XL with 5 minutes unattended rest
timeFrame: 24 Hours: from Visit 1 and Visit 2 (from groups 1 and 2)
measure: Omron HEM 907XL unattended versus Omron HEM 907XL partially attended
timeFrame: 24 hours: from Visit 1 and Visit 2 (group 3)
measure: Omron HEM 907XL unattended versus ABPM device
timeFrame: 24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Hypertension Unit of The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Marcel Ruzicka, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: