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OBPM_Meds2023: 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

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorAktiia SA

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy and bitherapy)

    Other intervention

    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: * Perindopril MEPHA (Angiotensin Converting Enzyme (ACE) inhibitors). * Indapamide MEPHA (Diuretics). * Amlodipine MEPHA (Calcium channel blockers). In each study treatment period, subjects in GROUP 1 will receive one of the following for each treatment period: monotherapy with Indapamide, bitherapy with Indapamide plus Perindopril, or bitherapy with Perindopril plus Amlodipine.

  • Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy)

    Other intervention

    Study drugs: * Perindopril MEPHA (Angiotensin Converting Enzyme (ACE) inhibitors). * Indapamide MEPHA (Diuretics). * Amlodipine MEPHA (Calcium channel blockers). In each study treatment period, subjects in GROUP 2 will receive one of the following monotherapies: Perindopril , Indapamide, or Amlodipine.

  • Aktiia Optical Blood Pressure Monitoring (OBPM) device and individualized antihypertensive treatment

    Other intervention

    For study GROUP 3: Subjects will be prescribed an individualized new antihypertensive treatment at their consultation with the Investigator at Visit 1.

Treatment groups

35 Participants
are divided into 3 treatment groups
Group A: Meds2023 GROUP 1Other 1 intervention
Group B: Meds2023 GROUP 2Other 1 intervention
Group C: Meds2023 GROUP 3Other 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Last 3 days of the washout period (week 1), against the last 3 days of the treatment period (week 3)
2

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)

Time frame
Last 3 days of the washout period (week 5), against the last 3 days of the treatment period (week 7)
3

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)

Time frame
Last 3 days of the washout period (week 9), against the last 3 days of the treatment period (week 11)

Secondary outcomes

1

Participant's compliance

Number of measurements made each day by the Aktiia System

Time frame
GROUP 1= 13 weeks; GROUP 2= 19 weeks; GROUP 3= 4 weeks.
2

Participant's compliance

Number of successful synchronizations with the Aktiia System

Time frame
GROUP 1= 13 weeks; GROUP 2= 19 weeks; GROUP 3= 4 weeks.
3

Participant's perception

Compilation of answers to the surveys

Time frame
GROUP 1= 13 weeks; GROUP 2= 19 weeks; GROUP 3= 4 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aktiia SA

Lead sponsor

Source ClinicalTrials.gov
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