COOL-BP Study: Continuous Versus Occasional Blood Pressure Study

Sponsor

Aktiia SA (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05211648

Collaborator

(none)

Enrollment

Location

Arm

14.6

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Device: Aktiia Bracelet	N/A

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 partipants 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 patient sat 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 Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a prospective open-label single arm study.This is a prospective open-label single arm study.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

COOL-BP Study: Continuous Versus Occasional Blood Pressure Study

Actual Study Start Date :

Feb 10, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Diastolic and Systolic Pressures Circadian profiles [6 months]
Analysis of the evolution of Diastolic and Systolic Pressures circadian profiles of each patient during the study.
Quality of life surveys [6 months]
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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

26 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harvard Medical School	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Aktiia SA

Investigators

Principal Investigator: Naomi Fisher, MD, Harvard Medical School Boston MA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aktiia SA

ClinicalTrials.gov Identifier:

NCT05211648

Other Study ID Numbers:

OBPM_Remote2021

First Posted:

Jan 27, 2022

Last Update Posted:

Feb 14, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Aktiia SA

hypertension

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Feb 14, 2022