Blood PressureNCT03862742
Role of Wrist Based Blood Pressure Monitoring in Clinical Practice
An observational study of Blood Pressure and Transitions of Care, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
This is a pilot clinical study to test the overarching hypothesis that frequent and longitudinal blood pressure monitoring with FDA approved consumer wrist based device during the patient transition from inpatient to home to the first clinic visit will elicit valuable BP data that can assist in physician treatment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Transitions of Care
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2019to Mar 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Individuals 18 years of age or older with and without the known diagnosis of hypertension (regardless of level of control or therapeutic regimen), able to operate HeartVue device, able to read, write, and speak English, level of "digital savviness" and owning an iOS or Android device will be recruited for participation in this pilot study.
Who may be able to join
- ≥18 years of age
- Own an iOS or Android device
Who cannot join
- Inability to give informed consent
- <18 years of age
- Inability to understand written English language
- Hypertensive urgency or emergency as an admission diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot clinical study to test the overarching hypothesis that frequent and longitudinal blood pressure monitoring with FDA approved consumer wrist based device during the patient transition from inpatient to home to the first clinic visit will elicit valuable BP data that can assist in physician treatment of hypertension
Read the detailed description
Wrist based health devices, often with mobile connectivity, that continuously or near continuously track heart rate, blood pressure, temperature, activity and sleep are growing in everyday popularity and beginning to enter the sphere of clinical relevance. However, their accuracy and utility for clinical use is largely unstudied. As these consumer devices, some of which are FDA approved, become more commonplace, it is paramount to understand their function, know their limitations, and be able to interpret results appropriately before incorporating them into our clinical practice. The AHA/ACC 2017 guideline makes a 1A recommendation for clinical use of out of office BP measurements(1). This recommendation is based on evidence that out of office BP and frequent and longitudinal BP measurements are important in predicting cardiovascular risk and monitoring treatment efficacy(2-5). This trend towards consumer driven digital health monitoring and the new AHA/ACC guideline are essentially advancing a consumer based precision medicine strategy for diagnosis and monitoring of hypertension. As this becomes commonplace in our patient population, we need rigorous clinical study of wrist base BP monitoring to better understand its role patient care.
- Conditions
- Blood Pressure, Transitions of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to the hospital | We will recruit patient volunteers from the Scripps Green Hospital and Scripps Memorial Hospital inpatient teaching services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
blood pressure measured by the wrist watch like blood pressure device
Measured: Pts will monitor BP during the transition from inpatient to home to the first clinic visit. BP measurements will be performed several times during the day and several times at night. The estimated time frame when data will be collected is 24 to 48 hours
Secondary outcomes (2)
Survey of healthcare providers
Survey to measure ease of use to the device in measuring blood pressure
Measured: A survey to measure how easy it is to use the device will be obtained at the completion of data collection. The estimated timeframe when the survey will be completed is 24 to 48 hours.
Survey of patients
Survey to measure ease of use to the device in measuring blood pressure
Measured: A survey to measure how easy it is to use the device will be obtained at the completion of data collection. The estimated timeframe when the survey will be completed is 24 to 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start22 May 2019
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Why it stopped: No participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Nicholson, MD PHD, Principal investigator, Scripps Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862742
- Sponsor's protocol ID
- IRB-18-7223
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2019
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Soc Hypertens. 2018 Aug;12(8):579.e1-579.e73. doi: 10.1016/j.jash.2018.06.010. No abstract available.
PubMed 30219548Drawz P. Clinical Implications of Different Blood Pressure Measurement Techniques. Curr Hypertens Rep. 2017 Jul;19(7):54. doi: 10.1007/s11906-017-0751-0.
PubMed 28551831O'Brien E, Parati G, Stergiou G, Asmar R, Beilin L, Bilo G, Clement D, de la Sierra A, de Leeuw P, Dolan E, Fagard R, Graves J, Head GA, Imai Y, Kario K, Lurbe E, Mallion JM, Mancia G, Mengden T, Myers M, Ogedegbe G, Ohkubo T, Omboni S, Palatini P, Redon J, Ruilope LM, Shennan A, Staessen JA, vanMontfrans G, Verdecchia P, Waeber B, Wang J, Zanchetti A, Zhang Y; European Society of Hypertension Working Group on Blood Pressure Monitoring. European Society of Hypertension position paper on ambulatory blood pressure monitoring. J Hypertens. 2013 Sep;31(9):1731-68. doi: 10.1097/HJH.0b013e328363e964.
PubMed 24029863Hermida RC, Ayala DE, Fernandez JR, Mojon A, Smolensky MH. Hypertension: New perspective on its definition and clinical management by bedtime therapy substantially reduces cardiovascular disease risk. Eur J Clin Invest. 2018 May;48(5):e12909. doi: 10.1111/eci.12909. Epub 2018 Feb 25.
PubMed 29423914Staessen JA, Thijs L, Fagard R, O'Brien ET, Clement D, de Leeuw PW, Mancia G, Nachev C, Palatini P, Parati G, Tuomilehto J, Webster J. Predicting cardiovascular risk using conventional vs ambulatory blood pressure in older patients with systolic hypertension. Systolic Hypertension in Europe Trial Investigators. JAMA. 1999 Aug 11;282(6):539-46. doi: 10.1001/jama.282.6.539.
PubMed 10450715
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Wrist Based Blood Pressure Monitoring in Clinical Practice
- ClinicalTrials.gov ID
- NCT03862742
- Acronym / sponsor ID
- IRB-18-7223
- Conditions
- Blood Pressure, Transitions of Care
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 5 Mar 2019 (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 is a pilot clinical study to test the overarching hypothesis that frequent and longitudinal blood pressure monitoring with FDA approved consumer wrist based device during the patient transition from inpatient to home to the first clinic visit will elicit valuable BP data that can assist in physician treatment of hypertension
Detailed description
Wrist based health devices, often with mobile connectivity, that continuously or near continuously track heart rate, blood pressure, temperature, activity and sleep are growing in everyday popularity and beginning to enter the sphere of clinical relevance. However, their accuracy and utility for clinical use is largely unstudied. As these consumer devices, some of which are FDA approved, become more commonplace, it is paramount to understand their function, know their limitations, and be able to interpret results appropriately before incorporating them into our clinical practice. The AHA/ACC 2017 guideline makes a 1A recommendation for clinical use of out of office BP measurements(1). This recommendation is based on evidence that out of office BP and frequent and longitudinal BP measurements are important in predicting cardiovascular risk and monitoring treatment efficacy(2-5). This trend towards consumer driven digital health monitoring and the new AHA/ACC guideline are essentially advancing a consumer based precision medicine strategy for diagnosis and monitoring of hypertension. As this becomes commonplace in our patient population, we need rigorous clinical study of wrist base BP monitoring to better understand its role patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to the hospital | – | –We will recruit patient volunteers from the Scripps Green Hospital and Scripps Memorial Hospital inpatient teaching services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals 18 years of age or older with and without the known diagnosis of hypertension (regardless of level of control or therapeutic regimen), able to operate HeartVue device, able to read, write, and speak English, level of "digital savviness" and owning an iOS or Android device will be recruited for participation in this pilot study.
Key inclusion criteria (2 listed)
- ≥18 years of age
- Own an iOS or Android device
Key exclusion criteria (4 listed)
- Inability to give informed consent
- <18 years of age
- Inability to understand written English language
- Hypertensive urgency or emergency as an admission diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood pressure
Time frame: Pts will monitor BP during the transition from inpatient to home to the first clinic visit. BP measurements will be performed several times during the day and several times at night. The estimated time frame when data will be collected is 24 to 48 hours
blood pressure measured by the wrist watch like blood pressure device
2 secondary outcomes
Survey of healthcare providers
Time frame: A survey to measure how easy it is to use the device will be obtained at the completion of data collection. The estimated timeframe when the survey will be completed is 24 to 48 hours.
Survey of patients
Time frame: A survey to measure how easy it is to use the device will be obtained at the completion of data collection. The estimated timeframe when the survey will be completed is 24 to 48 hours.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Background: PubMed 30219548Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Soc Hypertens. 2018 Aug;12(8):579.e1-579.e73. doi: 10.1016/j.jash.2018.06.010. No abstract available.
- Background: PubMed 28551831Drawz P. Clinical Implications of Different Blood Pressure Measurement Techniques. Curr Hypertens Rep. 2017 Jul;19(7):54. doi: 10.1007/s11906-017-0751-0.
- Background: PubMed 24029863O'Brien E, Parati G, Stergiou G, Asmar R, Beilin L, Bilo G, Clement D, de la Sierra A, de Leeuw P, Dolan E, Fagard R, Graves J, Head GA, Imai Y, Kario K, Lurbe E, Mallion JM, Mancia G, Mengden T, Myers M, Ogedegbe G, Ohkubo T, Omboni S, Palatini P, Redon J, Ruilope LM, Shennan A, Staessen JA, vanMontfrans G, Verdecchia P, Waeber B, Wang J, Zanchetti A, Zhang Y; European Society of Hypertension Working Group on Blood Pressure Monitoring. European Society of Hypertension position paper on ambulatory blood pressure monitoring. J Hypertens. 2013 Sep;31(9):1731-68. doi: 10.1097/HJH.0b013e328363e964.
- Background: PubMed 29423914Hermida RC, Ayala DE, Fernandez JR, Mojon A, Smolensky MH. Hypertension: New perspective on its definition and clinical management by bedtime therapy substantially reduces cardiovascular disease risk. Eur J Clin Invest. 2018 May;48(5):e12909. doi: 10.1111/eci.12909. Epub 2018 Feb 25.
- Background: PubMed 10450715Staessen JA, Thijs L, Fagard R, O'Brien ET, Clement D, de Leeuw PW, Mancia G, Nachev C, Palatini P, Parati G, Tuomilehto J, Webster J. Predicting cardiovascular risk using conventional vs ambulatory blood pressure in older patients with systolic hypertension. Systolic Hypertension in Europe Trial Investigators. JAMA. 1999 Aug 11;282(6):539-46. doi: 10.1001/jama.282.6.539.
- 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.
Laura Nicholson, MD PHD principal investigator
Scripps Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Transitions of Care, run by Scripps Translational Science Institute at 1 site 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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 21 Mar 2025. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Blood pressure (time frame: Pts will monitor BP during the transition from inpatient to home to the first clinic visit. BP measurements will be performed several times during the day and several times at night. The estimated time frame when data will be collected is 24 to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03862742, which also lists 5 linked publications.
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 Mar 2025.