HypertensionNCT05356754
VL-3 Training Study
A study testing The Vital Labs Digital Blood Pressure Monitor in people with Hypertension and Blood Pressure, run by Riva Health at 3 sites in United States.
Trial summary
The primary endpoints for this study are mean and standard deviation error measurements for the VLDBPM versus manual auscultation. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Blood Pressure
- What is being tested?
- The Vital Labs Digital Blood Pressure Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jul 2020to 8 Nov 2021
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female ≥18 and ≤ 85 years of age at the Baseline Visit.
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- A minimum of 30% of the data will be derived from male subjects; and a minimum of 30% of the data will be derived from female subjects.
- A minimum of 50 participants will have dark skin types, as defined by the Fitzpatrick Skin Type classification V or VI.
- Also, at least 10 participants should exhibit finger calluses, found typically on individuals who play stringed instruments frequently.
Who cannot join
- 1. Pregnant and/or breastfeeding. 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- 3. Are unable or unwilling to undergo all assessments associated with the study.
- 4. Have a history of poor quality or difficulty performing auscultation measurements.
- 5. Subjects shall be excluded if the Korotkoff sound [fifth phase (K5)] is not audible 6. Subjects with vascular implants in the arm of measurement, such as those used for dialysis 7. Subject suffering from a medical condition prohibiting blood flow occlusion in either arms.
- 8. Pre-existing conditions that may interfere with the accuracy or interpretation of auscultatory readings, such as aortic coarctation, arterial-venous malformation, occlusive arterial disease, or the presence of an antecubital bruit.
- 9. Subjects who have known allergies to nitroglycerin (for subjects undergoing the nitroglycerin challenge).
Show all 9Show fewer
- 10. Subjects who have taken short acting nitroglycerin within 4 hours of the scheduled study. Such studies will be deferred for at least 4 hours.
- 11. Subjects who have taken long acting nitroglycerin within 8 hours of the scheduled study. Such studies will be deferred for at least 8 hours.
- 12. Subjects with pericardial tamponade, restrictive cardiomyopathy, or constrictive pericarditis, or cardiac output is dependent upon venous return
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Hospital
Aurora, Colorado, 80045
University of California San Francisco
San Francisco, California, 94143
Diablo Clinical Research
Walnut Creek, California, 94398
About this study
Official title: PROSPECTIVE STUDY EVALUATING THE VITAL LABS DIGITAL BLOOD PRESSURE MONITOR (VLDBPM)
The primary endpoints for this study are mean and standard deviation error measurements for the VLDBPM versus manual auscultation.
Read the detailed description
This is a prospective, controlled, single-arm clinical evaluation. Five hundred thirty-two (532) subjects are planned to be evaluated. Each subject's blood pressure will be measured using the VLDBPM and manual auscultation. Each subject will be observed while undergoing a series of blood pressure perturbation challenges. Means measurement differences from the test sensor and the reference auscultation measurements will be used to validate the accuracy of the VDBPM software system.
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Total duration of subject participation will be 1 to 1.5 hours. Total duration of the study is expected to be 6 months.
Following medical history and patient eligibility assessments, eligible patients will be offered participation in the study. Once subjects are consented/enrolled, measurements will be performed in accordance with Data Collection Procedure section below.
- Conditions
- Hypertension, Blood Pressure
- Being tested
- The Vital Labs Digital Blood Pressure Monitor
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Vital Labs Digital Blood Pressure MonitorDevice
The Vital Labs Digital Blood Pressure monitor is a software-as-a-medical device (SaMD) that is capable of determining blood pressure, after calibration, using waveform changes observed in photoplethysmogram signals.
| Study group | Role | What they receive |
|---|---|---|
| The Vital Labs Digital Blood Pressure Monitor | Experimental | The Vital Labs Digital Blood Pressure monitor is a software-as-a-medical device (SaMD) that is capable of determining blood pressure, after calibration, using waveform changes observed in photoplethysmogram signals. The VLDBPM captures PPG signals using the existing camera systems on iPhones. These PPG signals are normalized and processed to determine markers of blood pressure change. These markers, when transformed using a predetermined model, are capable of determining blood pressure changes from a known (calibration) set-point. Receives: Device: The Vital Labs Digital Blood Pressure Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference between BP measures
Primary efficacy
Measured: Baseline
Standard deviation of differences between BP measures
Primary Efficacy
Measured: Baseline
Mean difference between BP measures
Primary efficacy
Measured: 1.5 hours
Standard deviation of differences between BP measures
Primary Efficacy
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start13 Jul 2020
- Primary completion8 Nov 2021
- Study completion8 Nov 2021
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riva Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Diablo Clinical Research, University of Colorado, Denver
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356754
- Sponsor's protocol ID
- CP-0001
- Status last verified
- Apr 2022
- First submitted
- 22 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE STUDY EVALUATING THE VITAL LABS DIGITAL BLOOD PRESSURE MONITOR (VLDBPM)
- ClinicalTrials.gov ID
- NCT05356754
- Acronym / sponsor ID
- CP-0001
- Conditions
- Hypertension, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Riva HealthIndustry (pharma, biotech, devices)
- Collaborators
- Diablo Clinical Research, University of Colorado, Denver
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 2 May 2022 (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.
The primary endpoints for this study are mean and standard deviation error measurements for the VLDBPM versus manual auscultation.
Detailed description
This is a prospective, controlled, single-arm clinical evaluation. Five hundred thirty-two (532) subjects are planned to be evaluated. Each subject's blood pressure will be measured using the VLDBPM and manual auscultation. Each subject will be observed while undergoing a series of blood pressure perturbation challenges. Means measurement differences from the test sensor and the reference auscultation measurements will be used to validate the accuracy of the VDBPM software system.
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Total duration of subject participation will be 1 to 1.5 hours. Total duration of the study is expected to be 6 months.
Following medical history and patient eligibility assessments, eligible patients will be offered participation in the study. Once subjects are consented/enrolled, measurements will be performed in accordance with Data Collection Procedure section below.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Vital Labs Digital Blood Pressure Monitor | Experimental | Device: The Vital Labs Digital Blood Pressure MonitorThe Vital Labs Digital Blood Pressure monitor is a software-as-a-medical device (SaMD) that is capable of determining blood pressure, after calibration, using waveform changes observed in photoplethysmogram signals. The VLDBPM captures PPG signals using the existing camera systems on iPhones. These PPG signals are normalized and processed to determine markers of blood pressure change. These markers, when transformed using a predetermined model, are capable of determining blood pressure changes from a known (calibration) set-point. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥18 and ≤ 85 years of age at the Baseline Visit.
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- A minimum of 30% of the data will be derived from male subjects; and a minimum of 30% of the data will be derived from female subjects.
- A minimum of 50 participants will have dark skin types, as defined by the Fitzpatrick Skin Type classification V or VI.
- Also, at least 10 participants should exhibit finger calluses, found typically on individuals who play stringed instruments frequently.
Key exclusion criteria (9 listed)
- 1. Pregnant and/or breastfeeding. 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- 3. Are unable or unwilling to undergo all assessments associated with the study.
- 4. Have a history of poor quality or difficulty performing auscultation measurements.
- 5. Subjects shall be excluded if the Korotkoff sound [fifth phase (K5)] is not audible 6. Subjects with vascular implants in the arm of measurement, such as those used for dialysis 7. Subject suffering from a medical condition prohibiting blood flow occlusion in either arms.
- 8. Pre-existing conditions that may interfere with the accuracy or interpretation of auscultatory readings, such as aortic coarctation, arterial-venous malformation, occlusive arterial disease, or the presence of an antecubital bruit.
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 |
|---|---|---|
| The Vital Labs Digital Blood Pressure MonitorThe Vital Labs Digital Blood Pressure monitor is a software-as-a-medical device (SaMD) that is capable of determining blood pressure, after calibration, using waveform changes observed in photoplethysmogram signals. | Device | The Vital Labs Digital Blood Pressure Monitor |
Primary outcome
Mean difference between BP measures
Time frame: Baseline
Primary efficacy
Standard deviation of differences between BP measures
Time frame: Baseline
Primary Efficacy
Mean difference between BP measures
Time frame: 1.5 hours
Primary efficacy
Standard deviation of differences between BP measures
Time frame: 1.5 hours
Primary Efficacy
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 2 May 2022.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Vital Labs Digital Blood Pressure Monitor in people with Hypertension and Blood Pressure, run by Riva Health at 3 sites in United States.
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 5 inclusion and 9 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 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 between BP measures (time frame: Baseline). The study lists 4 primary outcomes in all. 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 2 May 2022.