Clinical trial NCT05211648: COOL-BP Study: Continuous Versus Occasional Blood Pressure Study
Official title: COOL-BP Study: Continuous Versus Occasional Blood Pressure Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
Lead sponsor: Aktiia SA
Sponsor class: INDUSTRY
First posted: 2022-01-27
Enrollment: 55
Sex: ALL
Minimum age (years): 26
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective open-label single arm study.
Primary purpose: DIAGNOSTIC

Brief summary: The COOL-BP study is part of the Remote Hypertension Program and will investigate the data provided by Aktiia Bracelet (a cuffless Blood Pressure monitor at the wrist) when integrated into the Remote Hypertension Program.

The COOL BP study aims to compare weekly and monthly Blood Pressure averages measured manually by traditional Home Blood Pressure Monitoring to those measured automatically by the Aktiia bracelet.

Detailed description: This is a prospective open-label single arm study. The investigational device of this study is the Aktiia Bracelet device. Aktiia Bracelet is a non-invasive blood pressure (BP) monitor intended to track systolic and diastolic Blood Pressure trends. The Aktiia Bracelet can also measure heart rate.

Participants who consent to participate in COOL-BP will be shipped an Aktiia device to participants' residence.

For 6 months, patient will continue the procedures of the Remote Hypertension Program in parallel to wearing the Aktiia Bracelet. The Remote Hypertension Program is run remotely according to a clinical algorithm, where study navigators contact patients at regular intervals and monitor symptoms by regular phone calls; laboratory tests are obtained to ensure safety of the protocol's prescribed medications. Any symptoms will be evaluated by the program nurse practitioner or physician and managed per standard of care. During the study, the patient completes several surveys to give opinion on Aktiia product versus Home Blood Pressure Monitoring.

Following six months of using the Aktiia.product, the participant's participation in this study will end. Participants continued participation in the Remote Hypertension Program will depend on whether participants have met the blood pressure goals outlined in that program.

Eligibility criteria: Inclusion Criteria:

* Fluent in written and spoken English
* Already enrolled in the Remote Hypertension Program
* Average of last 3 office blood pressures \>140/90 mm Hg in last 18 months OR Last office blood pressure \>140/90 mm Hg in last 6 months OR Referred by MD and last 1 blood pressure \>130/80 mm Hg
* Own an iPhone

Exclusion Criteria:

* Tachycardia (heart rate at rest \> 120bpm)
* Atrial fibrillation, persistent
* Severe heart failure (LVEF\<35%)
* Pheochromocytoma
* Raynaud's disease
* Trembling and shivering
* Known pregnancy
* Breastfeeding
* Arteriovenous fistula
* Arm amputation
* Exfoliative skin disease
* Lymphoedema
* Known allergy to silicone
* Not Massachusetts resident
* Last MGB office visit \>3 years
* No-MGB provider
* Terminal medical condition
* CKD 4-5 (eGFR ≤ 30 mL/mn)

Primary outcomes:
measure: Diastolic and Systolic Pressures differences between weekly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data.
timeFrame: 6 months
measure: Diastolic and Systolic Pressures differences between monthly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data.
timeFrame: 6 months
Secondary outcomes:
measure: Diastolic and Systolic Pressures Circadian profiles
timeFrame: 6 months
measure: Quality of life surveys
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Medical School
state: Massachusetts
Study officials:
affiliation: Harvard Medical School Boston MA
name: Naomi Fisher, MD
role: PRINCIPAL_INVESTIGATOR
References: