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Completed

NCT Number: NCT05211648

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

26 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard Medical School

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Aktiia Bracelet

Device

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.

Primary outcomes

  1. Diastolic and Systolic Pressures differences between weekly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data.

    Time frame: 6 months

    Diastolic and Systolic Pressures are measured weekly manually by traditional Home Blood Pressure Monitoring and continuously with the Aktiia bracelet.

  2. Diastolic and Systolic Pressures differences between monthly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data.

    Time frame: 6 months

    Diastolic and Systolic Pressures are measured monthly manually by traditional Home Blood Pressure Monitoring and continuously with the Aktiia bracelet.

Secondary outcomes

  1. Diastolic and Systolic Pressures Circadian profiles

    Time frame: 6 months

    Analysis of the evolution of Diastolic and Systolic Pressures circadian profiles of each patient during the study.

  2. Quality of life surveys

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Aktiia SA

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2022
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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