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Идёт набор NCT07626879

Feasibility and Effectiveness of a Ring-Type Blood Pressure Device (CART-BP) Compared With 24-Hour Ambulatory Blood Pressure Monitoring in HFrEF

— Наблюдательное Heart Failure With Reduced Ejection Fraction; Hypertension

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Heart Failure With Reduced Ejection Fraction; Hypertension. Базовые параметры: от 19 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
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Feasibility and Effectiveness of a RING-type Blood Pressure Measurement Device (CART-BP) Compared With 24-Hour Ambulatory Blood Pressure Monitoring Device in Patients With Heart Failure With Reduced Ejection Fraction (RING-HFrEF)

Обзор

This study aims to evaluate the feasibility and diagnostic accuracy of the CART-BP ring-type wearable blood pressure monitoring device in comparison with 24-hour ambulatory blood pressure monitoring (ABPM) in patients with heart failure with reduced ejection fraction (HFrEF, LVEF ≤ 40%). As a multi-center, prospective, exploratory study, 100 patients will be enrolled at two tertiary hospitals in South Korea. The agreement between the two devices in 24-hour mean, daytime, and nighttime blood pressure measurements will be assessed per ISO 81060-2:2018 criteria.

Подробное описание

Hypertension is a major risk factor and exacerbating cause of heart failure. Accurate blood pressure monitoring in HFrEF patients is critically important, as reduced left ventricular stroke volume and altered peripheral vascular hemodynamics may affect the accuracy of photoplethysmography (PPG)-based blood pressure measurement.

The CART-BP device uses PPG technology in a ring form factor to enable continuous, non-invasive blood pressure monitoring. This study will simultaneously measure blood pressure using CART-BP and standard 24-hour ABPM over a 24-hour period. Agreement will be assessed using ISO 81060-2:2018 Criteria 1 and 2. An interim analysis will be conducted after 40 participants are enrolled to assess preliminary agreement and determine whether to continue to the full enrollment of 100 participants.

Первичные конечные точки

  • Agreement between CART-BP and ABPM in 24-hour mean systolic and diastolic blood pressure [Срок оценки: 24 hours]
Вторичные конечные точки (6)
  • Agreement in daytime mean SBP and DBP between CART-BP and ABPM [Срок оценки: 24 hours]
  • Agreement in nighttime mean SBP and DBP between CART-BP and ABPM [Срок оценки: 24 hours]
  • Agreement in blood pressure dipping pattern between CART-BP and ABPM [Срок оценки: 24 hours]
  • Blood pressure variability (standard deviation) agreement between devices [Срок оценки: 24 hours]
  • Measurement adherence rate of ABPM (target: ≥ 80% valid readings in total enrolled patients) [Срок оценки: 24 hours]
  • Measurement adherence rate of CART-BP (target: ≥ 80% valid readings in total enrolled patients) [Срок оценки: 24 hours]

Критерии участия

Критерии включения

  • Age ≥ 19 years (male or female)
  • Diagnosed with heart failure and currently under treatment
  • Left ventricular ejection fraction (LVEF) ≤ 40% confirmed by echocardiography performed within 1 year prior to enrollment
  • Able to undergo both 24-hour ambulatory blood pressure monitoring and ring-type blood pressure measurement
  • Voluntarily provided written informed consent to participate in this clinical study

Критерии исключения

  • Office blood pressure: SBP < 90 mmHg, or DBP < 50 mmHg, or SBP > 180 mmHg, or DBP > 100 mmHg
  • Unable to perform 24-hour ambulatory blood pressure monitoring
  • Unable to wear or use the ring-type blood pressure device
  • Variability in three consecutive resting cuff blood pressure measurements ≥ 20 mmHg (SBP) or ≥ 10 mmHg (DBP)
  • Insufficient valid ABPM readings: < 25 daytime or < 12 nighttime measurements per ESH criteria; or < 25 daytime or < 12 nighttime valid readings from the ring-type device
  • Pregnant, suspected pregnancy, or breastfeeding
  • Judged by the investigator to be legally or mentally unfit to participate in the clinical study

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 1 центр
  • Keimyung University Dongsan Medical Center — Daegu

Идентификаторы

NCT: NCT07626879 · 2025-10-039-005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗