COOL-BP Study: Continuous Versus Occasional Blood Pressure Study

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josep Sola, PhD; Phone Number: +41797689800; Email: josep@aktiia.com
• Study Contact Backup: Name: Naomi Fisher, MD; Phone Number: 617-732-5661; Email: nfisher@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with Aktiia bracelet; This is a prospective open-label single arm study. Study participants will wear the Aktiia bracelet for 6 months and will continue in parallel the procedures of the Remote Hypertension Program.

Device: Aktiia Bracelet; Aktiia Bracelet is a CE-marked medical device that will be used in accordance with its instructions for use. The optical signals at the wrist are recorded non-invasively by means by the Aktiia bracelet. The Blood Pressure measurements are further determined from these optical signals and are compared to weekly and monthly Blood Pressure averages measured manually by traditional Home Blood Pressure Monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic and Systolic Pressures differences between weekly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data.	Diastolic and Systolic Pressures are measured weekly manually by traditional Home Blood Pressure Monitoring and continuously with the Aktiia bracelet.	6 months
Diastolic and Systolic Pressures differences between monthly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data.	Diastolic and Systolic Pressures are measured monthly manually by traditional Home Blood Pressure Monitoring and continuously with the Aktiia bracelet.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic and Systolic Pressures Circadian profiles	Analysis of the evolution of Diastolic and Systolic Pressures circadian profiles of each patient during the study.	6 months
Quality of life surveys	Participants complete the same survey at Day 30, Day 60 and Day 180 to give a feedback on participants' satisfaction and comfort regarding Aktiia product compared to Home Blood Pressure monitoring. Part of answers to surveys are based on satisfaction scales from 0 to 10 where 0 = "bad" and 10 = "good".	6 months

Collaborators and Investigators

• Sponsor: Aktiia SA
• Investigators: Principal Investigator: Naomi Fisher, MD, Harvard Medical School Boston MA

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: OBPM_Remote2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes