HypertensionCHANGE-BPNCT05746117
Continual vs. Routine Home Blood Pressure Monitoring and Management in Diverse Community Practice: CHANGE-BP
A study testing Aktiia Device and Upper arm cuff in people with Hypertension, run by Aktiia SA at 1 site in United States.
Trial summary
The purpose of the CHANGE-BP study is to examine the change in in-office measured Blood Pressure (BP) from baseline to end of study (6-months) between participants randomized to either 1) Continual Blood Pressure Monitoring (CBPM), which includes receiving Aktiia's novel cuffless BP Research System that has an… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Aktiia Device and Upper arm cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2024to 30 Dec 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-80 years old
- Owns a smartphone that is an Android or iOS with a data plan
- Fluent in written and spoken English as the technology is currently only available in English
- Average of 3 BP readings in last 18 months of >140/90 OR last in-office BP >140/90 in the last 6 months as documented in their Electronic Health Record
- Is a patient with Providence Health
- Willing to attend the 2 in-person study visits
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- Is not participating in another study that is designed to influence blood pressure
- Willing to wear the Aktiia bracelet for 6 months
- Willing to be randomized to either group
- Had a BMP in the last 12 months or is willing to get one at the discretion of the clinical pharmacist as standard of care
Who cannot join
- Blood pressure at the baseline in-office visit is too low (SBP <140 mmHg AND DBP <90 mmHg) OR is too high (SBP > 190 mmHg OR DBP > 120 mmHg)
- Tachycardia (heart rate at rest > 120bpm)
- Atrial fibrillation, persistent or chronic
- Cardiomyopathy with LVEF <40% documented within the past year
- Diabetes Mellitus
- Under active treatment for hyperthyroidism
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- Myxedema coma
- Subclavian stenosis
- Pheochromocytoma
- Raynaud's disease
- Trembling and shivering
- Known pregnancy
- Breastfeeding
- Arteriovenous fistula
- Arm amputation
- Exfoliative skin disease
- Lymphedema
- Known allergy to silicone
- Terminal medical condition with a life expectancy less than 2 years
- CKD 4-5 (eGFR ≤ 30 mL/min)
- Upper arm circumference < 22 cm or > 42 cm
- Wrist circumference < 14 cm or > 21 cm
- Adults unable to consent or who need a legally authorized representative to consent
- Currently incarcerated or detained in accordance with federal regulations regarding prisoners (e.g., 45 CFR 46 Subpart C)
- Diagnosed whitecoat hypertension
- On hospice or going on hospice in the next 6-months
- Currently undergoing or will undergo active IV infusions for chemotherapy
- Any condition which, at the discretion of the enrolling investigator, would preclude their ability to comply with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Health & Services
Portland, Oregon, 97225
About this study
The purpose of the CHANGE-BP study is to examine the change in in-office measured Blood Pressure (BP) from baseline to end of study (6-months) between participants randomized to either 1) Continual Blood Pressure Monitoring (CBPM), which includes receiving Aktiia's novel cuffless BP Research System that has an accompanying Aktiia Patient Interface smartphone application, and care delivered through a centralized Aktiia Provider Interface that displays device data and is accessible by a health care professional or 2) Home Blood Pressure Monitoring (HBPM), which includes a standard oscillometric blood pressure cuff and the standard blood pressure management care from a participant's primary care physician.
Read the detailed description
This is a prospective, unblinded, open-label, randomized clinical trial that will study the use of the investigational Aktiia Bracelet and an accompanying Provider Interface in hypertension management. The Aktiia Bracelet is a non-invasive blood pressure monitor intended to track systolic and diastolic blood pressure and heart rate.
Participants will attend a baseline visit, which will include a survey and blood pressure and anthropometric measurements. Participants will then be randomized to either the CBPM group, which includes the Aktiia Bracelet and care through a centralized Aktiia Provider Interface, or the HBPM group, which includes a standard blood pressure cuff and standard hypertension care. Individuals in the CBPM group will wear the Aktiia Bracelet for 6 months. During this time, a study-affiliated clinical pharmacist will monitor the individual's blood pressure through the Provider Interface and will potentially titrate the participant's blood pressure medications accordingly. After 6-months, all participants will return for an end of study visit that will include a survey and blood pressure and anthropometric measurements. Participants in the CBPM group will complete an additional survey to give their opinion on the Aktiia product.
- Conditions
- Hypertension
- Being tested
- Aktiia Device, Upper arm cuff
- Keywords
- Hypertension, Medical Device
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aktiia DeviceDevice
The Aktiia Bracelet is a CE-marked medical device that will be used in accordance with its instructions for use. The bracelet non-invasively measures optical signals at the wrist, which are used to determine blood pressure. The bracelet comes with a bluetooth enabled upper arm cuff that can be used to take on-demand blood pressure measurements. All measurements are transmitted to a dashboard that a clinical pharmacist monitors during the participant's enrollment in the study.
Upper arm cuffDevice
A standard upper arm oscillometric cuff that can be used to take blood pressure at home.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Blood Pressure Monitoring (CBPM) | Experimental | Participants will wear the Aktiia Bracelet for 6-months and potentially receive blood pressure medication titrations during the 6-month period. Receives: Device: Aktiia Device |
| Home Blood Pressure Monitoring (HBPM) | Active comparator | Participants will receive an upper arm cuff and standard hypertension care from their primary care physician. Receives: Device: Upper arm cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Determine if there is a statistically greater reduction in in-office measured blood pressure from baseline to 6-months in the CBPM arm when compared to the HBPM arm
Measured: 6-months
Secondary outcomes (4)
Participant perception
Statistics on participants' perception of an optical BP monitoring modality as compared to an oscillometric cuff
Measured: 6-months
Participant engagement
Statistics on participants' engagement with the Aktiia Research System over the 6-month period
Measured: 6-months
Participant compliance
Statistics on participants' compliance, which is operationalized as the number of measurements made each day by the Aktiia Research System and the number of times the user syncs their Aktiia bracelet with the Patient Interface for the CBPM arm. Statistics on the number of upper arm cuff measurements reported to their PCP in the HBPM arm.
Measured: 6-months
Participant sociodemographics
Statistics on the sociodemographic breakdown of the sample
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start15 Dec 2024 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Why it stopped: Study aborted by the sponsor
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aktiia SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aaron Shoenkerman, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746117
- Sponsor's protocol ID
- OBPM_CHANGE-BP2022
- Acronym
- CHANGE-BP
- Status last verified
- Jan 2024
- First submitted
- 17 Feb 2023
- Last updated
- 18 Feb 2025
- 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 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continual vs. Routine Home Blood Pressure Monitoring and Management in Diverse Community Practice: CHANGE-BP
- ClinicalTrials.gov ID
- NCT05746117
- Acronym / sponsor ID
- CHANGE-BP / OBPM_CHANGE-BP2022
- Conditions
- Hypertension
- Keywords
- Hypertension, Medical Device
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study aborted by the sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aktiia SAIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Feb 2023 (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 purpose of the CHANGE-BP study is to examine the change in in-office measured Blood Pressure (BP) from baseline to end of study (6-months) between participants randomized to either 1) Continual Blood Pressure Monitoring (CBPM), which includes receiving Aktiia's novel cuffless BP Research System that has an accompanying Aktiia Patient Interface smartphone application, and care delivered through a centralized Aktiia Provider Interface that displays device data and is accessible by a health care professional or 2) Home Blood Pressure Monitoring (HBPM), which includes a standard oscillometric blood pressure cuff and the standard blood pressure management care from a participant's primary care physician.
Detailed description
This is a prospective, unblinded, open-label, randomized clinical trial that will study the use of the investigational Aktiia Bracelet and an accompanying Provider Interface in hypertension management. The Aktiia Bracelet is a non-invasive blood pressure monitor intended to track systolic and diastolic blood pressure and heart rate.
Participants will attend a baseline visit, which will include a survey and blood pressure and anthropometric measurements. Participants will then be randomized to either the CBPM group, which includes the Aktiia Bracelet and care through a centralized Aktiia Provider Interface, or the HBPM group, which includes a standard blood pressure cuff and standard hypertension care. Individuals in the CBPM group will wear the Aktiia Bracelet for 6 months. During this time, a study-affiliated clinical pharmacist will monitor the individual's blood pressure through the Provider Interface and will potentially titrate the participant's blood pressure medications accordingly. After 6-months, all participants will return for an end of study visit that will include a survey and blood pressure and anthropometric measurements. Participants in the CBPM group will complete an additional survey to give their opinion on the Aktiia product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Blood Pressure Monitoring (CBPM) | Experimental | Device: Aktiia DeviceParticipants will wear the Aktiia Bracelet for 6-months and potentially receive blood pressure medication titrations during the 6-month period. |
| Home Blood Pressure Monitoring (HBPM) | Active comparator | Device: Upper arm cuffParticipants will receive an upper arm cuff and standard hypertension care from their primary care physician. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 21-80 years old
- Owns a smartphone that is an Android or iOS with a data plan
- Fluent in written and spoken English as the technology is currently only available in English
- Average of 3 BP readings in last 18 months of >140/90 OR last in-office BP >140/90 in the last 6 months as documented in their Electronic Health Record
- Is a patient with Providence Health
Key exclusion criteria (28 listed)
- Blood pressure at the baseline in-office visit is too low (SBP <140 mmHg AND DBP <90 mmHg) OR is too high (SBP > 190 mmHg OR DBP > 120 mmHg)
- Tachycardia (heart rate at rest > 120bpm)
- Atrial fibrillation, persistent or chronic
- Cardiomyopathy with LVEF <40% documented within the past year
- Diabetes Mellitus
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 |
|---|---|---|
| Aktiia DeviceThe Aktiia Bracelet is a CE-marked medical device that will be used in accordance with its instructions for use. The bracelet non-invasively measures optical signals at the wrist, which are used to determine blood pressure. The bracelet comes with a bluetooth enabled upper arm cuff that can be used to take on-demand blood pressure measurements. All measurements are transmitted to a dashboard that a clinical pharmacist monitors during the participant's enrollment in the study. | Device | Continuous Blood Pressure Monitoring (CBPM) |
| Upper arm cuffA standard upper arm oscillometric cuff that can be used to take blood pressure at home. | Device | Home Blood Pressure Monitoring (HBPM) |
Primary outcome
Change in blood pressure
Time frame: 6-months
Determine if there is a statistically greater reduction in in-office measured blood pressure from baseline to 6-months in the CBPM arm when compared to the HBPM arm
4 secondary outcomes
Participant perception
Time frame: 6-months
Participant engagement
Time frame: 6-months
Participant compliance
Time frame: 6-months
Participant sociodemographics
Time frame: 6-months
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 18 Feb 2025.
- 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.
Aaron Shoenkerman, MD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aktiia Device and Upper arm cuff in people with Hypertension, run by Aktiia SA 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 10 inclusion and 28 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 18 Feb 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?
Change in blood pressure (time frame: 6-months). 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 18 Feb 2025.