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NCT Number: NCT06688409

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

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.

Recruiting

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location status: Recruiting

Location contact

Guylaine Marcotte

CONTACT

[email protected]

+1-514-338-2222

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

awake ABPM

Diagnostic Test

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

Primary outcomes

  1. Mean difference in systolic BP

    Time frame: At enrollment (time 0)

    Mean difference in systolic BP between the home BP device and the awake ABPM

Secondary outcomes

  1. Mean difference in diastolic BP

    Time frame: At enrollment (time 0)

    Mean difference in diastolic BP between the home BP device and the awake ABPM

  2. Mean difference in systolic BP from validated device

    Time frame: At enrollment (time 0)

    Mean difference in systolic BP between the non-validated home BP device and the validated home BP device

  3. Mean difference in diastolic BP from validated device

    Time frame: At enrollment (time 0)

    Mean difference in diastolic BP between the non-validated home BP device and the validated home BP device

Study contacts

Contact information is provided by the study sponsor or research team.

Remi Goupil, MD MSc

CONTACT

[email protected]

514-338-2883

Sponsors and collaborators

Lead sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Other

Registry information

Official study title

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

Acronym: VALID-HomeBP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 14, 2024
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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