Multicentric Prospective Clinical Study to Evaluate the Aktiia Optical Blood Pressure Monitoring (OBPM) Device Compared to Standard Home Blood Pressure Monitoring (HBPM) in Hypertensive Patients When Blood Pressure Lowering Medications Intake

Study Overview
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Brief Summary
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Prospective, multicentric, randomised, comparative study Study duration: 13 weeks in total Population: 30 hypertensive (Stage 1 or 2) participants (25 participants minimum) Device Under Test (DUT): Aktiia device Reference: HBPM (Aktiia cuff) Periods of treatment: 2 weeks of treatment for each drug followed by a washout period of 2 weeks (3 drugs in total with a fixed dose, drug intake order is randomly assigned)

Detailed Description
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This study with N = 30 participants (25 participants minimum) over 4 visits has been designed to compare Aktiia device systolic and diastolic blood pressure measurements against HBPM reference measurements in participants taking 3 successive BP lowering drugs during 2 weeks per treatment. Periods of treatment are followed by 2 weeks of washout. Study participants are hypertensive Stage 1 (SBP 140-159 mmHg or DBP 90-99 mmHg) or hypertensive Stage 2 (SBP 160-179 mmHg or DBP 100-109 mmHg) or for subjects aged ≥65yo SBP≥ 160 mmHg, naive of antihypertensive treatments at the inclusion in the study and during the conduct of the study apart from the study drugs. Study participants are asked to: Wear Aktiia bracelet continuously every day during 13 weeks in total, Initialize their bracelet with Aktiia cuff at different timepoints, Measure their blood pressure with an HBPM (Aktiia cuff) twice per day, Take their BP lowering medications during the treatment periods (2 weeks of treatment for each drug and 3 drugs in total), Complete 3 different surveys to give their feedback on Aktiia product use compared to HBPM.

Official Title
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Multicentric Prospective Clinical Study to Evaluate the Aktiia Optical Blood Pressure Monitoring (OBPM) Device Compared to Standard Home Blood Pressure Monitoring (HBPM) in Hypertensive Patients When Blood Pressure Lowering Medications Intake

Conditions
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Hypertension

Intervention / Treatment
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* Other: Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects aged 21 to 85 years old Subjects that can read and speak French Subjects that own a smart phone that uses either the iOS or Android operating system Hypertensive Stage 1 (SBP 140-159 mmHg or DBP 90-99 mmHg) or Hypertensive Stage 2 (SBP 160-179 mmHg or DBP 100-109 mmHg) or for subjects aged > 65yo SBP ≥160 mmHg, Naive of antihypertensive drugs at the inclusion in the study (no antihypertensive drugs taken in the last 3 months before Visit 1) and during the conduct of the study apart from the study drugs Subjects agreeing to attend all 4 on-site visits and follow study procedures Subjects that have signed the informed consent form Exclusion Criteria: Subjects have contraindications to the study drugs Subjects with Hypertension Stage 3 (SBP/DBP >180/110 mmHg) Subjects having medical interventions or taking treatments during the study that could have an impact on their BP Subjects with tachycardia (heart rate at rest > 120bpm) Subjects with atrial fibrillation Cardio myopathy (FE<40%) Severe valvular disease Implanted devices such as a pacemaker or defibrillator Subjects with diabetes Subjects with renal dysfunctions (eGFR < 45mL/min/1.73 m2 for patients between 21-85 yo) Subjects with hyper-/hypothyroidism Subjects with pheochromocytoma Subjects with Raynaud's disease Subjects with an arteriovenous fistula Women in known pregnancy Subjects with trembling and shivering Subjects with lymphoedema Low or elevated potassium level: threshold ≤3.5 mmol/L or ≥4.8 mmol/L Presence of an intravascular device Subjects with exfoliative skin diseases Subjects with arm paralysis Subjects with arm amputation Subjects with upper arm circumference < 22cm or > 42cm Subjects with wrist circumference > 23cm

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Study participants are asked to wear the Aktiia bracelet continuously every day for 13 weeks in total and initialize their Aktiia bracelet with the Aktiia cuff at different timepoints. In parallel, study participants are asked to take 3 successive Blood Pressure lowering drugs during 2 weeks per treatment. Treatment periods are followed by 2 weeks of washout. The order of drug intake is randomly assigned for every participant.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Meds2023 Cohort<br>Study participants are asked to wear the Aktiia bracelet continuously every day for 13 weeks in total and initialize their Aktiia bracelet with the Aktiia cuff at different timepoints. In parallel, study participants are asked to take 3 successive Blood Pressure lowering drugs during 2 weeks per treatment. Treatment periods are followed by 2 weeks of washout (no treatment). | Other: Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs<br>* The device under test is Aktiia Optical Blood Pressure Monitoring (OBPM) device and the comparator is the Aktiia cuff. The 3 drug treatments are the following ones: Perindopril 5 mg (Angiotensin Converting Enzyme (ACE) inhibitors) Indapamide 1.5 mg (Diuretics) Amlodipine 5 mg (Calcium channel blockers)<br>* Other names: Aktiia system, Aktiia device, Aktiia bracelet, Aktiia cuff;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 1 versus last 3 days of week 3) | Statistics on the comparison of the changes in average daytime Blood Pressure values pre- and post-intervention between the two modalities (Aktiia device and HBPM) | Last 3 days of the washout period (week 1), against the last 3 days of the treatment period (week 3) | 
| Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 5 versus last 3 days of week 7) | Statistics on the comparison of the changes in average daytime Blood Pressure values pre- and post-intervention between the two modalities (Aktiia device and HBPM) | Last 3 days of the washout period (week 5), against the last 3 days of the treatment period (week 7) | 
| Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 9 versus last 3 days of week 11) | Statistics on the comparison of the changes in average daytime Blood Pressure values pre- and post-intervention between the two modalities (Aktiia device and HBPM) | Last 3 days of the washout period (week 9), against the last 3 days of the treatment period (week 11) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant's compliance | Number of measurements made each day by the Aktiia System | 13 weeks | 
| Participant's compliance | Number of successful synchronizations with the Aktiia System | 13 weeks | 
| Participant's perception | Compilation of answers to the surveys | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Blood Pressure