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Autonomic response detection through Non-invasive beat-to-beat recording during Self-blood pressure measurement In Adults

Autonomic response detection through Non-invasive beat-to-beat recording during Self-blood pressure measurement In Adults - ANSIA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42901
Enrollment
50
Registered
2016-04-26
Start date
2016-05-12
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

blood pressure monitoring hypertension

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Any subject who was previously enrolled in the home vs ambulatory BP study (AMSTERDAM study, NL 40014.018.12)

Exclusion criteria

Exclusion criteria: * Pregnancy * Severe heart rate irregularities of any cause * Not able to follow instructions for BP measurement for any reason * Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study

Design outcomes

Primary

MeasureTime frame
The principal parameter is the difference in the maximal BP response between subjects with and without previously established BP differences during self-measurement of at least 10/5 mmHg compared to baseline values.

Secondary

MeasureTime frame
As secondary parameters we will consider the difference in HRV and BRS between subjects with and without incremental BP differences during self-measurement compared to basal values of at least 10/5 mmHg.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)