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Идёт набор NCT07523269

WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control

Без фазы С лечением Hypertension (HTN)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Aktiia G1 BP monitor for 12 months, Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months.
Кому может быть актуально
Состояния в реестре: Hypertension (HTN). Базовые параметры: 21 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

The WEARABLE-BP study will evaluate the clinical value of obtaining continual measurements using the Aktiia G1 Optical Blood Pressure Monitoring (OBPM) device in hypertensive patients, compared to using a traditional upper arm cuff for home BP monitoring. The WEARABLE-BP study aims to compare the change in unattended automated office blood pressure from baseline to 6 months between two study groups: those given an Aktiia G1 BP monitor and those given a traditional upper arm BP cuff.

Подробное описание

This is a prospective open-label two-arm randomized clinical trial (RCT). The investigational device of this study is the Aktiia G1 BP monitor.

There is an active 6- month comparison period between two BP monitoring devices, followed by a 6-month follow-up period when all patients will have an Aktiia G1 BP monitor.

Each participant will be randomly assigned to one of two study groups: Group 1, or Group 2. The randomization will be a simple, based on a single computer-generated sequence of random assignments.

* Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention 82 participants. These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period. * Group 2: Traditional BP monitor (upper arm cuff) - active control 82 participants. These participants will receive a traditional BP monitor (validated upper arm cuff) to use for the 6 months comparison period. At the 6-month visit, they will return the traditional BP monitor and receive an Aktiia G1 BP monitor for the 6-month follow-up period.

During the study, the patient completes online survey covering lifestyle, health, and socioeconomic environment.

Вмешательства

  • Устройство Aktiia G1 BP monitor for 12 months
    These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.
  • Устройство Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months
    These participants will receive a traditional BP monitor (validated upper arm cuff) to use for the 6 months comparison period. At the 6-month visit, they will return the traditional BP monitor and receive an Aktiia G1 BP monitor for the 6-month follow-up period.

Первичные конечные точки

  • Change in automated unattended office BP between the two groups from baseline to 6 months [Срок оценки: 6 months]
Вторичные конечные точки (3)
  • Percentage of hypertensive subjects achieving BP control at 6 months in the intervention group compared to the standard treatment group [Срок оценки: 6 months]
  • Difference in patient engagement and lifestyle features between the 2 groups [Срок оценки: 0, 6 and 12 months]
  • Difference in mean average Aktiia G1 BP measurement after a 6-month period [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Adults aged 21 to 85 years.
  • Able to read and speak English.
  • Have an MGB provider and medical record number in EPIC
  • Study participants will wear the Aktiia bracelet for 6 months
  • Willing to attend two on-site study visits and comply with all study procedures.
  • Signed informed consent provided.
  • Own a smartphone with iOS or Android operating system.
  • Hypertensive with uncontrolled systolic blood pressure (SBP) >135 mm Hg by unattended automated office measurement
  • Currently taking 0, 1 or 2 antihypertensive medications.

Критерии исключения

  • Severe hypertension (SBP > 180 mmHg or DBP > 120 mmHg).
  • Pregnant or breastfeeding.
  • Known severe heart failure (LVEF < 35%).
  • Known severe valvular heart disease.
  • Known pheochromocytoma.
  • Known severe chronic kidney disease (CKD stage 4-5; eGFR < 30 mL/min/1.73 m²).
  • Known uncontrolled hyperthyroidism or hypothyroidism.
  • Known severe diabetes (Hemoglobin A1c > 10%).
  • Known resting heart rate > 120 bpm.
  • Known persistent atrial fibrillation.
  • Known Raynaud's disease.
  • Known tremors or shivering disorders.
  • Known exfoliative skin diseases.
  • Known allergy to silicone.
  • Presence of lymphedema.
  • Paralysis of the arm.
  • Arm amputation.
  • Presence of implanted devices, such as a pacemaker, defibrillator, intravascular device, or arteriovenous fistula.
  • Upper arm circumference < 22 cm or > 42 cm.
  • Wrist circumference > 23 cm.
  • Mastectomy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Mass General Brigham Hospital — Boston

Идентификаторы

NCT: NCT07523269 · WEARABLE-BP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗