Evaluation of the auto-cuff response in outpatients with and without hypertension

Evaluation of the *auto-cuff* response in outpatients with and without hypertension - Evaluation of the *auto-cuff* response

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44268

Enrollment

Registered

2017-10-13

Start date

2017-10-27

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Hypertensie high blood pressure Hypertension

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Aged *18 years; - Patient visiting the outpatient clinic of the Department of Vascular Medicine at the AMC.

Exclusion criteria

Exclusion criteria: - Pregnancy; - Severe heart rate irregularities of any cause; - Severe uncontrolled hypertension (mean BP>200/120 mmHg in the clinic); - Not able to follow instructions for BP measurement for any reason; - Recently changed BP lowering medication (

Design outcomes

Primary

Measure	Time frame
Main study parameter/endpoint: The principal parameter is the difference in the average systolic BP, defined as the mean BP during self-measurement using continuous beat-to-beat BP registration, between semi-automated and fully-automated BP measurement compared to baseline values.	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints: o Differences in average diastolic BP, defined as the mean BP during self-measurement using continuous beat-to-beat BP registration, between semi-automated and fully-automated BP measurement compared to baseline values; o Differences in the maximal rise in BP (systolic and diastolic), defined as the maximum BP during the first 20 seconds of each self-measurement using continuous beat-to-beat BP registration; o Differences in heart rate (HR), defined as the inverse of the interbeat interval, during each self-measurement using continuous beat-to-beat BP registration; o Differences in cardiac output (CO), defined as the stroke volume (SV) divided by the interbeat interval, during each self-measurement using continuous beat-to-beat BP registration; o Differences in systemic vascular resistance (SVR) during each self-measurement using continuous beat-to-beat BP registration calculated as the ratio of MAP and CO.	—

Measure

Time frame

Secondary study parameters/endpoints: o Differences in average diastolic BP, defined as the mean BP during self-measurement using continuous beat-to-beat BP registration, between semi-automated and fully-automated BP measurement compared to baseline values; o Differences in the maximal rise in BP (systolic and diastolic), defined as the maximum BP during the first 20 seconds of each self-measurement using continuous beat-to-beat BP registration; o Differences in heart rate (HR), defined as the inverse of the interbeat interval, during each self-measurement using continuous beat-to-beat BP registration; o Differences in cardiac output (CO), defined as the stroke volume (SV) divided by the interbeat interval, during each self-measurement using continuous beat-to-beat BP registration; o Differences in systemic vascular resistance (SVR) during each self-measurement using continuous beat-to-beat BP registration calculated as the ratio of MAP and CO.

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Countries

Netherlands

Outcome results