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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Switzerland
HUG
NOT_YET_RECRUITING
Geneva
CHUV
RECRUITING
Lausanne
Contact Information
Primary
Nermine Laaboub, PhD
nermine.laaboub@aktiia.com
+41786598389
Backup
Pascale Vermare, Master
pascale.vermare@aktiia.com
Time Frame
Start Date:2023-06-29
Estimated Completion Date:2026-12-31
Participants
Target number of participants:35
Treatments
Other: Meds2023 GROUP 1
GROUP 1 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, GROUP 1 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: Meds2023 GROUP 2
GROUP 2 participants are asked to wear the Aktiia bracelet continuously every day for 19 weeks in total and initialize their Aktiia bracelet with the Aktiia cuff at different timepoints.~In parallel, GROUP 2 participants are asked to stop their previous antihypertensive monotherapy for the first 2 weeks of the study participation and then take 3 successive blood pressure-lowering medications during 2 weeks per treatment. Treatment periods are followed by 2 weeks of washout (no treatment). Finally, they resume their initial monotherapy intake for a period of 4 weeks.
Other: Meds2023 GROUP 3
GROUP 3 participants are asked to wear the Aktiia bracelet continuously every day for 4 weeks in total and initialize their Aktiia bracelet with the Aktiia cuff at different timepoints.~In parallel, GROUP 3 participants are asked to take their initial antihypertensive medication that doesn't allow them to have controlled blood pressure for 1 week. For the following 3 weeks of the study participation, GROUP 3 participants are asked to take an individualized antihypertensive therapy assigned by the investigator.