Evaluation of the Satisfaction of a Hypertensive Population in Their Use of the Aktiia 24/7 Blood Pressure Monitor (OBPM_HTN2024)

OBPM_HTN2024 Study Evaluation of the Satisfaction of a Hypertensive Population in Their Use of the Aktiia 24/7 Optical Blood Pressure Monitoring (OBPM) Device: a Prospective Observational Clinical Study Across the United States

OBPM_HTN2024 study was designed by AKTIIA SA to evaluate how a hypertensive population, reflective of the United States and encompassing a range of phenotypes, perceives the Aktiia 24/7 device (Aktiia G1) during their first 3 months of use.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension

• Study Type: Observational
• Enrollment (Estimated): 5000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population should cover the following phenotypes:

• Closed to 50% females and 50% males,
• At least 20% of non-Caucasian subjects
• At least 20% of subjects with SBP≥150mmHg.

Description

Inclusion Criteria:

1. Adult subjects aged 21 to 85 years old

2. Hypertensive subjects either:

   • Stage 1: SBP 145-159 mmHg or DBP 90-99 mmHg; or
   • Stage 2: SBP 160-179 mmHg or DBP 100-109 mmHg; or
   • Stage 3: SYS ≥ 180mmHg and DIA ≥ 110mmHg
3. Subjects living in the US
4. Subjects that can read and speak English
5. Subjects that own a smart phone that uses either the iOS or Android operating system
6. Subjects agreeing to follow study procedures
7. Subjects that have signed the informed consent form

Exclusion Criteria:

1. Subjects with tachycardia (heart rate at rest > 120bpm)
2. Subjects with atrial fibrillation
3. Cardio myopathy (FE<40%)
4. Severe valvular disease
5. Implanted devices such as a pacemaker or defibrillator
6. Subjects with diabetes
7. Subjects with renal dysfunctions (eGFR < 45mL/min/1.73 m2)
8. Subjects with hyper-/hypothyroidism
9. Subjects with pheochromocytoma
10. Subjects with Raynaud's disease
11. Subjects with an arteriovenous fistula
12. Women in known pregnancy
13. Subjects with trembling and shivering
14. Subjects with lymphoedema
15. Low or elevated potassium level: threshold ≤3.5 mmol/L or ≥4.8 mmol/L
16. Presence of an intravascular device
17. Subjects with exfoliative skin diseases
18. Subjects with arm paralysis
19. Subjects with arm amputation
20. Subjects with upper arm circumference < 22cm or > 42cm
21. Subjects with wrist circumference > 23cm

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study cohort; Each study subject will receive an Aktiia device and will use it continuously for 3 months. Study participants will have to complete 2 different surveys: one at baseline, and one after the 3 months of Aktiia device use to give their perception on the Aktiia device use as compared to other blood pressure monitors currently on the US market.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preferences of subjects regarding the method to monitor their blood pressure between Aktiia Bracelet, Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor	Number of participants with preferences using Aktiia Bracelet, Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor to monitor their blood pressure.	3 months
Frequency of Aktiia app use	Number of of blood pressure data checks on the Aktiia mobile app per week (0 / 1-5 / 6-10 / 11-20 / 20+)	3 months
Frequency of use of Aktiia device as compared to previously use other blood pressure monitors	Position of each subject regarding whether they think they have used the Aktiia device more frequently as compared to other blood pressure monitors previously used out of study context (Yes/No)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of subject's experience in using the Aktiia App	Description of the study subject regarding their experience using the Aktiia Mobile App (It was very difficult to use / It was somewhat difficult to learn to use / It was neither easy nor difficult / It is easy to use / It was very easy to use)	3 months
Evaluation of the most valuable data on the Aktiia Mobile App by subjects	Most valuable Aktiia app data according to subjects (Daily averages / Weekly averages / Monthly averages / Percent of BP time in target range /Day vs night blood pressure comparison /Visual graph of values)	3 months

Collaborators and Investigators

• Sponsor: Aktiia SA

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: OBPM_HTN2024

Drug and device information, study documents

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