COOL-BP Study: Continuous Versus Occasional Blood Pressure Study

Hypertension Clinical Trial

Official title:

COOL-BP Study: Continuous Versus Occasional Blood Pressure Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05211648
• Other study ID #: OBPM_Remote2021
• Status: Completed
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: May 23, 2023

Study information

• Verified date: May 2023
• Source: Aktiia SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 23, 2023
• Est. primary completion date: May 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	Harvard Medical School	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Aktiia SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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