Hypertension Clinical Trial
Official title:
Blood Pressure Measurement: Should Technique Define Targets?
NCT number | NCT03267420 |
Other study ID # | 6486 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 12, 2017 |
Est. completion date | August 31, 2019 |
Verified date | March 2021 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | August 31, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | The Hypertension Unit of The Ottawa Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute | The Physicians' Services Incorporated Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | BpTRU versus Omron HEM 907XL with 5 minutes unattended rest | The difference between average systolic blood pressure measured with BpTRU and Omron HEM907XL (both measured in mm Hg) will allow us to report the effect of the additional five minutes of rest | 24 Hours: from Visit 1 and Visit 2 (from groups 1 and 2) | |
Secondary | Omron HEM 907XL unattended versus Omron HEM 907XL partially attended | Difference between systolic blood pressure between the two visits in Group 3 will address an issue of unattended versus partially attended resting systolic blood pressure (both measured in mm Hg) | 24 hours: from Visit 1 and Visit 2 (group 3) | |
Secondary | Omron HEM 907XL unattended versus ABPM device | Difference between the average unattended systolic blood pressure and daytime average blood pressure from the 24 hour ABPM | 24 hours: from Visit 1 and Visit 2 (from groups 1, 2 and 3) |
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