About this trial
Study design: Prospective, multicentric, randomized, comparative study Study duration: between 4 and 19 weeks depending on the study group. Population: minimum 35 hypertensives (stage 1 or stage 2) participants divided into 3 groups depending on hypertension criteria. GROUP 1 = untreated hypertensives, stage 1 or stage 2; GROUP 2 = hypertensives, stage 1, who are taking antihypertensive monotherapy; GROUP 3 = hypertensives, stage 1 or stage 2, who are taking antihypertensive treatment that doesn't allow them to have controlled blood pressure.
Device Under Test (DUT): Aktiia device Reference: HBPM (Aktiia cuff) Periods of treatment: For GROUPS 1 and 2, 2 weeks of treatment for each antihypertensive medication followed by a washout period of 2 weeks (3 antihypertensive medications in total with a fixed dose; medication intake order is randomly assigned). For GROUP 3, an individualized new antihypertensive medication will be prescribed during the consultation with the investigator that will be administered for 3 weeks.
Eligibility criteria
Qualifiers
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,
Disqualifiers
Subjects have contraindications to the study drugs
Subjects with Hypertension Stage 3 (SBP/DBP >180/110 mmHg)
Subjects with orthostatic hypotension (a 20 mmHg decrease in systolic BP, or 10 mmHg decrease in diastolic BP when measured in the standing position after a 1-minute waiting period)
Subjects who are likely to be unable to perform the HBPM required for the study within the designated time frame (7 to 11
Trial design
Treatments tested in this trial
- Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy and bitherapy)
- Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy)
- Aktiia Optical Blood Pressure Monitoring (OBPM) device and individualized antihypertensive treatment