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Trial record 2 of 4 for:    Naomi Fisher
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COOL-BP Study: Continuous Versus Occasional Blood Pressure Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05211648
Recruitment Status : Completed
First Posted : January 27, 2022
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
Aktiia SA

Study Description
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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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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 : February 10, 2022
Actual Primary Completion Date : May 23, 2023
Actual Study Completion Date : May 23, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  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".


Eligibility Criteria
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Ages Eligible for Study:   26 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05211648


Locations
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United States, Massachusetts
Harvard Medical School
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Aktiia SA
Investigators
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Principal Investigator: Naomi Fisher, MD Harvard Medical School Boston MA
More Information
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Responsible Party: Aktiia SA
ClinicalTrials.gov Identifier: NCT05211648    
Other Study ID Numbers: OBPM_Remote2021
First Posted: January 27, 2022    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Aktiia SA:
hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases