Overview
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)
Description
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.
Eligibility
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