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Recruiting NCT06688409

Accuracy Testing of Validated and Non-validated Home BP Devices Sold on the Online Market.

No phase Interventional Hypertension

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: awake ABPM.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparing Home Blood Pressure Measurements from Devices with and Without Evidence of Validation to Ambulatory Blood Pressure Monitoring: the VALID-HomeBP Study

Overview

This study aims to assess whether validated and non-validated blood pressure measuring devices sold on the online market are accurate in regards to the mean awake BP from ambulatory blood pressure monitoring.

Interventions

  • Diagnostic test awake ABPM
    Comparison of a BP measured with the home BP devices and the average awake ABPM performed immediately after

Primary outcome measures

  • Mean difference in systolic BP [Time frame: At enrollment (time 0)]
Secondary outcome measures (3)
  • Mean difference in diastolic BP [Time frame: At enrollment (time 0)]
  • Mean difference in systolic BP from validated device [Time frame: At enrollment (time 0)]
  • Mean difference in diastolic BP from validated device [Time frame: At enrollment (time 0)]

Eligibility criteria

Inclusion criteria

  • Adults aged > 18 years scheduled to undergo an ABPM

Exclusion criteria

  • Upper arm size outside of cuff range of selected devices (<22 cm or >42 cm)
  • Night shift workers
  • Permanent atrial fibrillation
  • Known severe aortic stenosis
  • Contraindication to measure BP on the non-dominant arm
  • Ongoing pregnancy
  • Inability or unwillingness to provide consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Canada · 1 center
  • Hôpital Sacré-Coeur de Montréal — Montreal

Identifiers

NCT: NCT06688409 · VALID-HomeBP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗