Blood PressureNCT04307004
Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure
A study testing Unattended blood pressure measurement, Attended blood pressure measurement and Ambulatory blood pressure monitoring in people with Blood Pressure, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
The purpose of the proposed study is to test whether measuring unattended blood pressure using an automated blood pressure monitor in a clinic setting without staff being present can reduce the need for assessing out-of- clinic awake blood pressure using ambulatory monitoring. Read more about this study
- Who is it for?
- Ages 19 to 87 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Unattended blood pressure measurement, Attended blood pressure measurement and Ambulatory blood pressure monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 654 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2019to 13 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 87 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mean screening systolic blood pressure of 110 to < 160 mm Hg at most recent visit
- Mean screening diastolic blood pressure of 70 to <100 mm Hg at most recent visit
Who cannot join
- Currently taking antihypertensive medications
- Known to be currently pregnant
- History of sleep apnea
- History of heart attack, stroke, or any cardiovascular disease
- History of arrhythmia (e.g. - atrial fibrillation or ventricular tachycardia)
- Completed ambulatory blood pressure monitoring in the past year
- Second shift, overnight, or jobs that will not allow ambulatory blood pressure device to measure every 30 minutes for 24 hours.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham Hypertension Research Clinic
Birmingham, Alabama, 35205
Columbia University Medical Center - Hypertension Center
New York, New York, 10032
About this study
Official title: Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure - Better BP Study
The purpose of the proposed study is to test whether measuring unattended blood pressure using an automated blood pressure monitor in a clinic setting without staff being present can reduce the need for assessing out-of- clinic awake blood pressure using ambulatory monitoring. Also, the investigators will test whether asleep blood pressure can be accurately measured using a novel home blood pressure monitoring device with less burden compared with ambulatory monitoring.
Read the detailed description
For many people, blood pressure levels differ when measured in a doctor's office versus during normal daily activities. Ambulatory blood pressure monitoring, also called ABPM, involves wearing a blood pressure cuff attached to a device that is programmed to measure participants blood pressure every 30 minutes for a 24-hour period. ABPM can help better estimate a person's true average blood pressure. Although ABPM is recommended for diagnosing high blood pressure and it also measures blood pressure while people sleep, it is not available in many clinics and some people find the procedure to be uncomfortable. The purpose of this research study is to test whether blood pressure measured in a clinic setting without medical staff present is comparable to blood pressure levels measured during the daytime measured using an ABPM device. Also, the investigators will test whether asleep blood pressure can be accurately measured using a home blood pressure monitoring device. These findings may help identify new approaches for diagnosing high blood pressure without the need for ABPM. Each participant will complete four study visits. During the course of the study, participants will:
- Have their blood pressure measured in the clinic, six times at each of the first two study visits for a total of twelve blood pressure measurements.
- Complete questionnaires about their demographics, medical history, and participant sleeping habits.
- Have their blood drawn and provide a urine sample.
- Wear a Food and Drug Administration-approved ABPM device (Microlife WatchBP O3) for 24 hours.
- Wear a Food and Drug Administration-approved home blood pressure monitor (Microlife WatchBP Home N) while they sleep for one night.
- Wear an activity monitor (Actiwatch) for two 24-hour periods. The Actiwatch activity monitor measures activity levels and can be used to identify when they are asleep.
- Answer some questions about their experience while wearing the ABPM and home blood pressure monitor.
- Have an echocardiogram performed.
- Conditions
- Blood Pressure
- Being tested
- Unattended blood pressure measurement, Attended blood pressure measurement, Ambulatory blood pressure monitoring, Home blood pressure monitoring
- Keywords
- Ambulatory blood pressure monitoring, Home blood pressure monitoring, Clinic blood pressure, Blood pressure phenotypes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unattended blood pressure measurementOther
Also called Microlife WatchBP Office AFIB
Participants will have their blood pressure measured three times with an automated blood pressure monitor with a technician not present in the room.
Attended blood pressure measurementOther
Also called Microlife WatchBP Office AFIB
Participants will have their blood pressure measured three times with an automated blood pressure monitor with a technician present in the room.
Ambulatory blood pressure monitoringOther
Also called Microlife WatchBP O3
Participants will have their blood pressure measured every 30 minutes over 24-hours using an ambulatory blood pressure monitor.
Home blood pressure monitoringOther
Also called Microlife WatchBP Home N
Participants will have their blood pressure measured three times overnight while they are asleep using a home blood pressure monitor.
| Study group | Role | What they receive |
|---|---|---|
| Unattended vs Attended Blood Pressure | Other | Participants blood pressure will be measured three times attended and three times unattended using the Microlife WatchBP Office AFIB device. Whether investigators measure blood pressure attended first and then unattended or unattended first and then attended will be assigned using a random number generator. At visit 2, clinic blood pressure will be measured three times attended and three times unattended using the Microlife WatchBP Office AFIB device, as at visit 1, but in the reverse order. Receives: Other: Unattended blood pressure measurement; Other: Attended blood pressure measurement |
| ABPM vs HBPM | Other | Participants will be fitted with either the Microlife WatchBP O3 ambulatory blood pressure monitoring device or instructed on how to use the Microlife WatchBP Home N home blood pressure device, depending on which they are assigned to complete first. The order in which participants undergo ambulatory or home blood pressure monitoring will be assigned through a random number generator. Receives: Other: Ambulatory blood pressure monitoring; Other: Home blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Difference Between Unattended and Attended Blood Pressure
The difference between both systolic and diastolic blood pressure measurements when a technician is present versus when they are not present in the room.
Measured: 2 days
Accuracy of Measuring Asleep Blood Pressure Using a Home Blood Pressure Monitor as Compared to Using an Ambulatory Blood Pressure Monitor
Participants will have their systolic and diastolic blood pressure measured overnight using a home blood pressure monitor and over 24-hours using an ambulatory blood pressure monitor.
Measured: 2 days
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires
Participants will complete questionnaires regarding their experience wearing both the ambulatory and home blood pressure monitors as well as a questionnaire on their willingness to wear the devices again.
Measured: 3 days
Secondary outcomes (2)
Left Ventricular Mass Index
Mean left ventricular mass index (LVMI)
Measured: 3 days
Urinary Albumin-to-creatine Ratio
Mean urinary albumin-to-creatinine ratio (UACR)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start15 Jul 2019
- Primary completion12 Dec 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily B. Levitan, University of Alabama at Birmingham
- Investigators
- Paul Muntner, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307004
- Sponsor's protocol ID
- 5R01HL139716-02
- Other IDs
- R01HL139716
- Status last verified
- Dec 2024
- First submitted
- 2 Mar 2020
- Last updated
- 13 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cepeda M, Hubbard D, Oparil S, Schwartz JE, Jaeger BC, Hardy ST, Medina J, Chen L, Muntner P, Shimbo D. Evaluating novel approaches for estimating awake and sleep blood pressure: design of the Better BP Study - a randomised, crossover trial. BMJ Open. 2022 Jun 6;12(6):e058140. doi: 10.1136/bmjopen-2021-058140.
PubMed 35667722
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure - Better BP Study
- ClinicalTrials.gov ID
- NCT04307004
- Acronym / sponsor ID
- 5R01HL139716-02
- Conditions
- Blood Pressure
- Keywords
- Ambulatory blood pressure monitoring, Home blood pressure monitoring, Clinic blood pressure, Blood pressure phenotypes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 654 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Columbia University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Posted 12 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the proposed study is to test whether measuring unattended blood pressure using an automated blood pressure monitor in a clinic setting without staff being present can reduce the need for assessing out-of- clinic awake blood pressure using ambulatory monitoring. Also, the investigators will test whether asleep blood pressure can be accurately measured using a novel home blood pressure monitoring device with less burden compared with ambulatory monitoring.
Detailed description
For many people, blood pressure levels differ when measured in a doctor's office versus during normal daily activities. Ambulatory blood pressure monitoring, also called ABPM, involves wearing a blood pressure cuff attached to a device that is programmed to measure participants blood pressure every 30 minutes for a 24-hour period. ABPM can help better estimate a person's true average blood pressure. Although ABPM is recommended for diagnosing high blood pressure and it also measures blood pressure while people sleep, it is not available in many clinics and some people find the procedure to be uncomfortable. The purpose of this research study is to test whether blood pressure measured in a clinic setting without medical staff present is comparable to blood pressure levels measured during the daytime measured using an ABPM device. Also, the investigators will test whether asleep blood pressure can be accurately measured using a home blood pressure monitoring device. These findings may help identify new approaches for diagnosing high blood pressure without the need for ABPM. Each participant will complete four study visits. During the course of the study, participants will:
- Have their blood pressure measured in the clinic, six times at each of the first two study visits for a total of twelve blood pressure measurements.
- Complete questionnaires about their demographics, medical history, and participant sleeping habits.
- Have their blood drawn and provide a urine sample.
- Wear a Food and Drug Administration-approved ABPM device (Microlife WatchBP O3) for 24 hours.
- Wear a Food and Drug Administration-approved home blood pressure monitor (Microlife WatchBP Home N) while they sleep for one night.
- Wear an activity monitor (Actiwatch) for two 24-hour periods. The Actiwatch activity monitor measures activity levels and can be used to identify when they are asleep.
- Answer some questions about their experience while wearing the ABPM and home blood pressure monitor.
- Have an echocardiogram performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unattended vs Attended Blood Pressure | Other | Other: Unattended blood pressure measurement, Other: Attended blood pressure measurementParticipants blood pressure will be measured three times attended and three times unattended using the Microlife WatchBP Office AFIB device. Whether investigators measure blood pressure attended first and then unattended or unattended first and then attended will be assigned using a random number generator. At visit 2, clinic blood pressure will be measured three times attended and three times unattended using the Microlife WatchBP Office AFIB device, as at visit 1, but in the reverse order. |
| ABPM vs HBPM | Other | Other: Ambulatory blood pressure monitoring, Other: Home blood pressure monitoringParticipants will be fitted with either the Microlife WatchBP O3 ambulatory blood pressure monitoring device or instructed on how to use the Microlife WatchBP Home N home blood pressure device, depending on which they are assigned to complete first. The order in which participants undergo ambulatory or home blood pressure monitoring will be assigned through a random number generator. |
Who may qualify
- Ages
- 19 to 87 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mean screening systolic blood pressure of 110 to < 160 mm Hg at most recent visit
- Mean screening diastolic blood pressure of 70 to <100 mm Hg at most recent visit
Key exclusion criteria (7 listed)
- Currently taking antihypertensive medications
- Known to be currently pregnant
- History of sleep apnea
- History of heart attack, stroke, or any cardiovascular disease
- History of arrhythmia (e.g. - atrial fibrillation or ventricular tachycardia)
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 |
|---|---|---|
| Unattended blood pressure measurementAlso: Microlife WatchBP Office AFIBParticipants will have their blood pressure measured three times with an automated blood pressure monitor with a technician not present in the room. | Other | Unattended vs Attended Blood Pressure |
| Attended blood pressure measurementAlso: Microlife WatchBP Office AFIBParticipants will have their blood pressure measured three times with an automated blood pressure monitor with a technician present in the room. | Other | Unattended vs Attended Blood Pressure |
| Ambulatory blood pressure monitoringAlso: Microlife WatchBP O3Participants will have their blood pressure measured every 30 minutes over 24-hours using an ambulatory blood pressure monitor. | Other | ABPM vs HBPM |
| Home blood pressure monitoringAlso: Microlife WatchBP Home NParticipants will have their blood pressure measured three times overnight while they are asleep using a home blood pressure monitor. | Other | ABPM vs HBPM |
Primary outcome
Absolute Difference Between Unattended and Attended Blood Pressure
Time frame: 2 days
The difference between both systolic and diastolic blood pressure measurements when a technician is present versus when they are not present in the room.
Accuracy of Measuring Asleep Blood Pressure Using a Home Blood Pressure Monitor as Compared to Using an Ambulatory Blood Pressure Monitor
Time frame: 2 days
Participants will have their systolic and diastolic blood pressure measured overnight using a home blood pressure monitor and over 24-hours using an ambulatory blood pressure monitor.
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires
Time frame: 3 days
Participants will complete questionnaires regarding their experience wearing both the ambulatory and home blood pressure monitors as well as a questionnaire on their willingness to wear the devices again.
2 secondary outcomes
Left Ventricular Mass Index
Time frame: 3 days
Urinary Albumin-to-creatine Ratio
Time frame: 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35667722Cepeda M, Hubbard D, Oparil S, Schwartz JE, Jaeger BC, Hardy ST, Medina J, Chen L, Muntner P, Shimbo D. Evaluating novel approaches for estimating awake and sleep blood pressure: design of the Better BP Study - a randomised, crossover trial. BMJ Open. 2022 Jun 6;12(6):e058140. doi: 10.1136/bmjopen-2021-058140.
- 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.
Paul Muntner, PhD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unattended blood pressure measurement, Attended blood pressure measurement and Ambulatory blood pressure monitoring in people with Blood Pressure, run by University of Alabama at Birmingham at 2 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 2 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 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absolute Difference Between Unattended and Attended Blood Pressure (time frame: 2 days). The study lists 3 primary outcomes in all. 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 NCT04307004, which also lists 1 linked publication.
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 13 Dec 2024.