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

Официальное название

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

Обзор

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.

Подробное описание

This study with N = 35 participants minimum, over 2 to 6 visits, depending on the study group, has been designed to compare Aktiia device systolic and diastolic blood pressure measurements against HBPM reference measurements in participants taking 3 successive BP-lowering medications during 2 weeks per treatment for GROUPS 1 and 2, while GROUP 3 will receive, during 3 weeks, an individualized medication decided by the investigator. For GROUPS 1 and 2, periods of treatment are followed by 2 weeks of washout.

Study participants are: For GROUP 1, 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) that are naive of antihypertensive treatments at the inclusion in the study. For GROUP 2, hypertensives Stage 1 (SBP 140-159 mmHg or DBP 90-99 mmHg) with no other cardiovascular risk factors who are taking an antihypertensive monotherapy, for whom previous treatment will be stopped at the study inclusion and will be resumed for the last 4 weeks of the study participation. For GROUP 3, uncontrolled 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) who are taking antihypertensive treatment that doesn't allow them to have controlled blood pressure.

Study participants are asked to:

Wear the Aktiia bracelet continuously every day for 4 to 19 weeks in total, depending on the study group, Initialize their bracelet with the Aktiia cuff at different time points, Measure their blood pressure with an HBPM (Aktiia cuff) twice per day, Take their BP-lowering medications during the treatment periods, Complete 2 to 3 different surveys, depending on the study group, to give their feedback on Aktiia product use compared to HBPM.

Вмешательства

• Другое 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 bith
• Другое 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.
• Другое 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.

Первичные конечные точки

• Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 1 versus last 3 days of week 3) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Last 3 days of the washout period (week 9), against the last 3 days of the treatment period (week 11)]

Вторичные конечные точки (3)

• Participant's compliance [Срок оценки: GROUP 1= 13 weeks; GROUP 2= 19 weeks; GROUP 3= 4 weeks.]
• Participant's compliance [Срок оценки: GROUP 1= 13 weeks; GROUP 2= 19 weeks; GROUP 3= 4 weeks.]
• Participant's perception [Срок оценки: GROUP 1= 13 weeks; GROUP 2= 19 weeks; GROUP 3= 4 weeks.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Subjects with arm amputation
• Subjects with upper arm circumference < 22cm or > 42cm
• Subjects with wrist circumference > 23cm
• Subjects with non-standard circadian rhythm, including shift workers and night workers
• Subjects who have received a mastectomy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Швейцария · 3 центра

• HUG — Geneva
• CHVR — Sion
• CHUV — Lausanne

Идентификаторы

NCT: NCT05780710 · OBPM_Meds2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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