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

NCT05780710 | Recruiting

• 1 other identifier: OBPM_Meds2023
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hypertension

Keywords

Hypertension; Blood Pressure

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (3)

• Participant's compliance

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

• Participant's compliance

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

• Participant's perception

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

Study Arms (3)

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).

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

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.

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

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.

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

Interventions

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.

Also known as: Aktiia system, Aktiia device, Aktiia bracelet, Aktiia cuff

Meds2023 GROUP 3

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: * 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.

Also known as: Aktiia system, Aktiia device, Aktiia bracelet, Aktiia cuff

Meds2023 GROUP 1

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

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.

Also known as: Aktiia system, Aktiia device, Aktiia bracelet, Aktiia cuff

Meds2023 GROUP 2

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Subjects agreeing to attend all 4 on-site visits and follow study procedures
• Subjects that have signed the informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Aktiia SA: lead

Study Sites (3)

HUG

Geneva, Canton of Geneva, 1205, Switzerland

TERMINATED

CHVR

Sion, Valais, 1951, Switzerland

WITHDRAWN

CHUV

Lausanne, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Antihypertensive Agents

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Cléo Moulin, Master

CONTACT

+41798336172; cleo.moulin@aktiia.com

Pascale Vermare, Master

CONTACT

pascale.vermare@aktiia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 22, 2023
• Study Start: June 29, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

CH (3)