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Home blood pressure monitors in patients with atrial fibrillation

Validation of home blood pressure monitors in patients with atrial fibrillation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16857539
Enrollment
33
Registered
2016-01-20
Start date
2015-09-28
Completion date
Unknown
Last updated
2021-10-04

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

Conditions

Atrial fibrillation Circulatory System Atrial fibrillation and flutter

Interventions

All participants attend the NIHR/Wellcome Trust Birmingham Clinical Research Facility for two separate study visits. 3 different blood pressure monitors will be tested following standard monitor valid

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Initial diagnosis of atrial fibrillation, confirmed by 12 lead electrocardiogram and judged by primary care physician to be eligible to participate 2. Aged 25 years or over 3. Recruitment blood pressures should be in the range 90–180mmHg for SBP and 40–130mmHg for DBP. If patients with blood pressures outside these ranges are available they may be included but only to a maximum of four such pressures. The number of subjects in each recruitment range (SBP: low 160mmHg; DBP: low 100mmHg) must be between 10 and 12 subjects.

Exclusion criteria

Exclusion criteria: Three failed attempts in machine measurement.

Design outcomes

Primary

MeasureTime frame
Percentage of test device measurements differing from the mercury standard by more than 5, 10 and 15mmHg.

Secondary

MeasureTime frame
1. Average BP value over 1, 2, 3, 4, and 5 readings versus that for 6 readings for each individual 2. Variability of oscillometric devices compared to standard mercury technique

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026