HypertensionVALID-HomeBPNCT06688409
Accuracy Testing of Validated and Non-validated Home BP Devices Sold on the Online Market.
A study testing awake ABPM in people with Hypertension, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- awake ABPM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 12 Feb 2024to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged > 18 years scheduled to undergo an ABPM
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Home Blood Pressure Measurements From Devices With and Without Evidence of Validation to Ambulatory Blood Pressure Monitoring: The VALID-HomeBP Study
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.
- Conditions
- Hypertension
- Being tested
- awake ABPM
- Keywords
- hypertension, blood pressure measurement, blood pressure, blood pressure device validation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
awake ABPMDiagnostic test
Comparison of a BP measured with the home BP devices and the average awake ABPM performed immediately after
| Study group | Role | What they receive |
|---|---|---|
| Validate home BP device | Active comparator | BP measured with a validated home BP device Receives: Diagnostic Test: awake ABPM |
| Non-validated home BP device #1 | Active comparator | BP measured with the first non-validated home BP device Receives: Diagnostic Test: awake ABPM |
| Non-validated home BP device #2 | Active comparator | BP measured with the second non-validated home BP device Receives: Diagnostic Test: awake ABPM |
| Non-validated home BP device #3 | Active comparator | BP measured with the third non-validated home BP device Receives: Diagnostic Test: awake ABPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in systolic BP
Mean difference in systolic BP between the home BP device and the awake ABPM
Measured: At enrollment (time 0)
Secondary outcomes (3)
Mean difference in diastolic BP
Mean difference in diastolic BP between the home BP device and the awake ABPM
Measured: At enrollment (time 0)
Mean difference in systolic BP from validated device
Mean difference in systolic BP between the non-validated home BP device and the validated home BP device
Measured: At enrollment (time 0)
Mean difference in diastolic BP from validated device
Mean difference in diastolic BP between the non-validated home BP device and the validated home BP device
Measured: At enrollment (time 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start12 Feb 2024
- Primary completion15 Oct 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remi Goupil, MD MSc, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688409
- Sponsor's protocol ID
- VALID-HomeBP
- Acronym
- VALID-HomeBP
- Status last verified
- Oct 2026
- First submitted
- 12 Nov 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Home Blood Pressure Measurements From Devices With and Without Evidence of Validation to Ambulatory Blood Pressure Monitoring: The VALID-HomeBP Study
- ClinicalTrials.gov ID
- NCT06688409
- Acronym / sponsor ID
- VALID-HomeBP / VALID-HomeBP
- Conditions
- Hypertension
- Keywords
- hypertension, blood pressure measurement, blood pressure, blood pressure device validation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 15 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Validate home BP device | Active comparator | Diagnostic Test: awake ABPMBP measured with a validated home BP device |
| Non-validated home BP device #1 | Active comparator | Diagnostic Test: awake ABPMBP measured with the first non-validated home BP device |
| Non-validated home BP device #2 | Active comparator | Diagnostic Test: awake ABPMBP measured with the second non-validated home BP device |
| Non-validated home BP device #3 | Active comparator | Diagnostic Test: awake ABPMBP measured with the third non-validated home BP device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged > 18 years scheduled to undergo an ABPM
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| awake ABPMComparison of a BP measured with the home BP devices and the average awake ABPM performed immediately after | Diagnostic test | Non-validated home BP device #1, Non-validated home BP device #2, Non-validated home BP device #3, Validate home BP device |
Primary outcome
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
3 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing awake ABPM in people with Hypertension, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in systolic BP (time frame: At enrollment (time 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.