Actively Recruiting
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
Led by Aktiia SA · Updated on 2026-02-05
35
Participants Needed
3
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 to 85 years
- Able to read and speak French
- Own a smartphone using iOS or Android
- Diagnosed with Stage 1 (SBP 140-159 mmHg or DBP 90-99 mmHg) or Stage 2 (SBP 160-179 mmHg or DBP 100-109 mmHg) hypertension, or SBP 60 mmHg if older than 65
- No antihypertensive drugs taken in the 3 months prior to study start and during the study except study medications
- Willing to attend all 4 on-site visits and follow study procedures
- Signed informed consent form
You will not qualify if you...
- Contraindications to study drugs
- Hypertension Stage 3 (SBP/DBP >180/110 mmHg)
- Orthostatic hypotension (significant BP drop when standing)
- Unable to perform required home blood pressure monitoring at set times
- Medical interventions or treatments affecting blood pressure during study
- For Groups 1 and 2: Target organ damage (left ventricular hypertrophy or high albumin/creatinine ratio)
- Resting heart rate above 120 bpm
- Atrial fibrillation
- Cardiomyopathy with ejection fraction below 40%
- Severe valvular heart disease
- Implanted pacemaker or defibrillator
- Diabetes
- Renal dysfunction (eGFR < 45 mL/min/1.73 m2)
- Hyperthyroidism or hypothyroidism
- Pheochromocytoma
- Raynaud's disease
- Presence of arteriovenous fistula
- Known pregnancy
- Trembling or shivering
- Lymphoedema
- Abnormal potassium levels (<3.5 or >4.8 mmol/L)
- Presence of intravascular device
- Exfoliative skin diseases
- Arm paralysis or amputation
- Upper arm circumference below 22 cm or above 42 cm
- Wrist circumference above 23 cm
- Non-standard circadian rhythm including shift or night workers
- Previous mastectomy
AI-Screening
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Trial Site Locations
Total: 3 locations
1
HUG
Geneva, Canton of Geneva, Switzerland, 1205
Terminated
2
CHVR
Sion, Valais, Switzerland, 1951
Withdrawn
3
CHUV
Lausanne, Switzerland, 1011
Actively Recruiting
Research Team
C
Cléo Moulin, Master
CONTACT
P
Pascale Vermare, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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