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

Recruiting now · Not applicable

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID: NCT05780710
Run by: Aktiia SA
People needed: 35
Starts: 2023-06-29
Expected to finish: 2026-12-31
Last updated by the study team: 2026-02-05

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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,
Naive of antihypertensive drugs at the inclusion in the study (no antihypertensive drugs taken in the last 3 months before Visit 1) and during the conduct of the study apart from the study drugs
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
Subjects with pheochromocytoma
Subjects with Raynaud's disease
Subjects with an arteriovenous fistula
Women in known pregnancy
Subjects with trembling and shivering
Subjects with lymphoedema
Low or elevated potassium level: threshold ≤3.5 mmol/L or ≥4.8 mmol/L
Presence of an intravascular device
Subjects with exfoliative skin diseases
Subjects with arm paralysis

Where it is running

CHUV — Lausanne, Switzerland (enrolling)
HUG — Geneva, Canton of Geneva, Switzerland
CHVR — Sion, Valais, Switzerland

Full record on ClinicalTrials.gov

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