RecruitingNot ApplicableNCT05780710

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

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


Sponsor

Aktiia SA

Enrollment

35 participants

Start Date

Jun 29, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 21 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a wrist-worn optical blood pressure monitoring device (made by Aktiia) to see if it accurately tracks blood pressure changes in people who are starting blood pressure medication for the first time. It compares readings from this wearable against standard home blood pressure monitoring. **You may be eligible if:** - You are between 21 and 85 years old - You speak and read French - You own a smartphone (iOS or Android) - You have been diagnosed with stage 1 or stage 2 high blood pressure (hypertension) - You have not taken any blood pressure medications in the past 3 months and are starting treatment for the first time as part of this study - You are willing to attend all 4 study visits **You may NOT be eligible if:** - You are already on blood pressure medication - You do not own a compatible smartphone - You cannot read French - You are not willing to take the study-prescribed blood pressure medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.

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

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.

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

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


Locations(3)

HUG

Geneva, Canton of Geneva, Switzerland

CHVR

Sion, Valais, Switzerland

CHUV

Lausanne, Switzerland

View Full Details on ClinicalTrials.gov

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NCT05780710


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