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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.
This study with N = 35 participants minimum, over 2 to 6 visits, depending on the study group, has been designed to compare Aktiia device systolic and diastolic blood pressure measurements against HBPM reference measurements in participants taking 3 successive BP-lowering medications during 2 weeks per treatment for GROUPS 1 and 2, while GROUP 3 will receive, during 3 weeks, an individualized medication decided by the investigator. For GROUPS 1 and 2, periods of treatment are followed by 2 weeks of washout.
Study participants are: For GROUP 1, 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) that are naive of antihypertensive treatments at the inclusion in the study. For GROUP 2, hypertensives Stage 1 (SBP 140-159 mmHg or DBP 90-99 mmHg) with no other cardiovascular risk factors who are taking an antihypertensive monotherapy, for whom previous treatment will be stopped at the study inclusion and will be resumed for the last 4 weeks of the study participation. For GROUP 3, uncontrolled 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) who are taking antihypertensive treatment that doesn't allow them to have controlled blood pressure.
Study participants are asked to:
Wear the Aktiia bracelet continuously every day for 4 to 19 weeks in total, depending on the study group, Initialize their bracelet with the Aktiia cuff at different time points, Measure their blood pressure with an HBPM (Aktiia cuff) twice per day, Take their BP-lowering medications during the treatment periods, Complete 2 to 3 different surveys, depending on the study group, to give their feedback on Aktiia product use compared to HBPM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meds2023 GROUP 1 | Other | 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). |
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| Meds2023 GROUP 2 | Other | 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. |
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| Meds2023 GROUP 3 | Other | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy and bitherapy) | Other | The device under test is Aktiia Optical Blood Pressure Monitoring (OBPM) device and the comparator is the Aktiia cuff. For study GROUP 1: Study drugs are:
|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Participant's compliance | Number of measurements made each day by the Aktiia System | GROUP 1= 13 weeks; GROUP 2= 19 weeks; GROUP 3= 4 weeks. |
| Participant's compliance | Number of successful synchronizations with the Aktiia System |
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Inclusion Criteria:
Exclusion Criteria:
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
a.m. and 4 to 9 p.m.).
Subjects having medical interventions or taking treatments during the study that could have an impact on their BP
For GROUPS 1 and 2 only: Subjects with target organ damage (left ventricular hypertrophy observed on ECG, and/ or, albumin/creatinine ratio in urine ≥3.5 mg/mmol)
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
Subjects with non-standard circadian rhythm, including shift workers and night workers
Subjects who have received a mastectomy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cléo Moulin, Master | Contact | +41798336172 | cleo.moulin@aktiia.com | |
| Pascale Vermare, Master | Contact | +33666992877 | pascale.vermare@aktiia.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUG | Terminated | Geneva | Canton of Geneva | 1205 | Switzerland | |
| CHVR |
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Study participants are asked to wear the Aktiia bracelet continuously every day for 4 to 19 weeks in total, depending on the study group, and initialize their Aktiia bracelet with the Aktiia cuff at different timepoints.
In parallel, GROUP 1 and 2 participants are asked to take 3 successive Blood Pressure lowering medications 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. GROUP 3 participants will receive and individualized antihypertensive medication assigned by the investigator.
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| Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy) | Other | Study drugs:
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| Aktiia Optical Blood Pressure Monitoring (OBPM) device and individualized antihypertensive treatment | Other | For study GROUP 3: Subjects will be prescribed an individualized new antihypertensive treatment at their consultation with the Investigator at Visit 1. |
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| GROUP 1= 13 weeks; GROUP 2= 19 weeks; GROUP 3= 4 weeks. |
| Participant's perception | Compilation of answers to the surveys | GROUP 1= 13 weeks; GROUP 2= 19 weeks; GROUP 3= 4 weeks. |
| Withdrawn |
| Sion |
| Valais |
| 1951 |
| Switzerland |
| CHUV | Recruiting | Lausanne | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000959 | Antihypertensive Agents |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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