MedTrace Logo

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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-02-05

No results posted yet for this study

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

Interventions

OTHER

Aktiia 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.

OTHER

Aktiia 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.

OTHER

Aktiia 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.

Sponsors & Collaborators

  • Aktiia SA

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-29
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05780710 on ClinicalTrials.gov