An interventional study of Aktiia Device and Upper arm cuff in Hypertension, sponsored by Aktiia SA. Withdrawn at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-18.
Sponsored by Aktiia SA · Not applicable, Interventional, and Treatment
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
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Exclusion Criteria:
Participants will wear the Aktiia Bracelet for 6-months and potentially receive blood pressure medication titrations during the 6-month period.
Device: Aktiia Device
Participants will receive an upper arm cuff and standard hypertension care from their primary care physician.
Device: Upper arm cuff
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.
A standard upper arm oscillometric cuff that can be used to take blood pressure at home.
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
Time frame: 6-months
Participant perception
Statistics on participants' perception of an optical BP monitoring modality as compared to an oscillometric cuff
Time frame: 6-months
Participant engagement
Statistics on participants' engagement with the Aktiia Research System over the 6-month period
Time frame: 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.
Time frame: 6-months
Participant sociodemographics
Statistics on the sociodemographic breakdown of the sample
Time frame: 6-months
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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