Ambulant versus unattended & attended office versus self-home blood pressure measurement

Ambulant versus unattended & attended office versus self-home blood pressure measurement - AMUSE-BP

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55589

Enrollment

120

Registered

2019-09-11

Start date

2020-02-10

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension en high blood pressure

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age of 18 years or older 2. Documented medical history of hypertension in local hospital electronic patient record 3. Stable dose of anti-hypertensive medication for at least 2 months (includes no current antihypertensive medication, diagnosis hypertension is enough) 4. SBP>90 and 60 and

Exclusion criteria

Exclusion criteria: 1. SBP >180 mmHg and/or DBP >110mmHg at inclusion screening visit (attended AOBP). 2. Any BP that according to the treating physician is not adequately controlled and needs medication adjustment

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints: The main study parameters are twofold: (1) Mean difference between HBPM and ABPM values calculated with the Bland-Altman method (2) Mean standard deviation (SD) of the mean difference between HBPM and ABPM calculated with the Bland-Altman method. - Both expressed in mmHg for both SB and DBP (see primary objective chapter 2). - The HBPM value is a 7-day average of systolic and diastolic BP - The ABPM value is an average BP measured by 24-hour ambulatory measurements	—

Measure

Time frame

Main study parameters/endpoints: The main study parameters are twofold: (1) Mean difference between HBPM and ABPM values calculated with the Bland-Altman method (2) Mean standard deviation (SD) of the mean difference between HBPM and ABPM calculated with the Bland-Altman method. - Both expressed in mmHg for both SB and DBP (see primary objective chapter 2). - The HBPM value is a 7-day average of systolic and diastolic BP - The ABPM value is an average BP measured by 24-hour ambulatory measurements

—

Secondary

Measure	Time frame
For all of the secondary objectives formulated in chapter 2 (objective A, B, C, D, E, F, G, H, I, J) the study parameters are the same as the main study parameters. For the last secondary objectives K the study parameters are: K: To investigate if a different protocol than the standard 7-day HBPM protocol results in clinically acceptable (	—

Countries

Netherlands

Outcome results