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Non-Invasive Hemodynamic Monitoring in Hospitalized Heart Failure

23 июня 2026 г. обновлено: Acorai AB

Hemodynamic Observational Study in Patients With Heart Failure Using a Non-Invasive Multi-Modal Sensing Device (HOSP-HF)

Heart failure hospitalization is associated with a high risk of early readmission and mortality. There is an unmet clinical need for low-burden, non-invasive methods to better understand congestion and hemodynamic status during hospitalization.

This observational study evaluates the association between non-invasive measurements obtained with the Acorai Device 1.0 and clinical data collected during hospitalization and up to 90 days after discharge in patients admitted with heart failure. The device performs short, non-invasive recordings that collect physiological signals from the thoracic region without influencing clinical care.

Participants will undergo daily recordings during hospitalization. Clinical information and outcomes, including heart failure hospitalization and all-cause mortality within 90 days after discharge, will be collected from medical records. The study aims to explore relationships between non-invasive sensor measurements and clinical outcomes in hospitalized heart failure patients.

Обзор исследования

Статус

Рекрутинг

Условия

Подробное описание

The Hemodynamic Observational Study in Patients with Heart Failure (HOSP-HF) is a prospective, multicenter observational cohort study conducted in hospitalized patients with a primary diagnosis of heart failure. The study is designed to evaluate associations between non-invasive physiological measurements obtained using the Acorai Device 1.0 and clinical parameters and outcomes.

The Acorai Device 1.0 is a non-invasive, handheld system that records multimodal thoracic signals during brief recordings of approximately five minutes. The device does not provide diagnostic output to clinicians and does not influence clinical management.

Eligible patients admitted with new or worsening heart failure will be enrolled during hospitalization. Participants will undergo daily non-invasive recordings with the device from admission until discharge. No additional diagnostic or therapeutic procedures are introduced by the study.

Clinical information including demographics, medical history, vital signs, laboratory values, and routine imaging findings will be collected from medical records where available. Outcomes including heart failure hospitalization and all-cause mortality will be assessed for 90 days following discharge from the index hospitalization.

The primary objective of the study is to assess the association between non-invasive sensor measurements and the composite outcome of heart failure hospitalization or all-cause mortality within 90 days after discharge. Exploratory analyses will evaluate changes in device measurements during hospitalization and their relationship with clinical parameters and outcomes.

The study is conducted at hospitals in the United States, Europe, and Singapore.

Тип исследования

Наблюдательный

Регистрация (Оцененный)

1000

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Имя: Warka AlHassani
Номер телефона: +46 709 72 60 97
Электронная почта: warka.alhassani@acorai.com

Места учебы

Швеция
- - Lund, Швеция
    - Рекрутинг
    - Skane University Hospital
    - Контакт:
      
      Oscar Braun
      
      Номер телефона: +46 46 17 36 90
      
      Электронная почта: oscar.braun@med.lu.se

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

Взрослый
Пожилой взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Невероятностная выборка

Исследуемая популяция

Adults hospitalized with a primary diagnosis of heart failure at participating hospitals in the United States, Europe, and Singapore. Eligible participants are patients experiencing new or worsening heart failure symptoms with objective evidence of congestion requiring initiation or intensification of heart failure-specific therapy during the index hospitalization.

Описание

Inclusion Criteria:

Age ≥18 years
Hospitalization for primary heart failure, defined as new or worsening heart failure symptoms with objective evidence of congestion requiring initiation or intensification of heart failure-specific therapy
Ability to provide written informed consent

Exclusion Criteria:

Any discretionary exclusion where the inclusion of the subject is deemed to pose potential risks to the subject's well-being or is likely to comprise the compliant performance of the study.
Pregnancy or lactation (as confirmed by self-report or medical documentation)
Presence of a skin rash or open wound in the area where the Acorai Device model 1.0 will be applied
Any other condition that, in the opinion of the investigator, would preclude the subject from participating in the study or may affect the integrity of the data

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Количество групп / когорт

Когорты и вмешательства

Группа / когорта
Hospitalized Heart Failure Patients Adults admitted to hospital with a primary diagnosis of heart failure who undergo daily non-invasive Acorai Device 1.0 measurements (~5-minute recordings) during hospitalization. Participants are followed through hospital discharge and for 90 days after discharge using clinical records to assess outcomes including heart failure hospitalization and all-cause mortality.

Группа / когорта

Hospitalized Heart Failure Patients

Adults admitted to hospital with a primary diagnosis of heart failure who undergo daily non-invasive Acorai Device 1.0 measurements (~5-minute recordings) during hospitalization. Participants are followed through hospital discharge and for 90 days after discharge using clinical records to assess outcomes including heart failure hospitalization and all-cause mortality.

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Composite of 90-Day Heart Failure Hospitalization or All-Cause Mortality Временное ограничение: 90 days after discharge from the index hospitalization	Occurrence of either heart failure hospitalization or death from any cause within 90 days following the index hospitalization.	90 days after discharge from the index hospitalization

Другие показатели результатов

Мера результата	Мера Описание	Временное ограничение
Association Between Non-Invasive Physiological Signals Recorded by the Acorai Device and 90-Day Clinical Outcomes Временное ограничение: Measurements collected from informed consent until hospital discharge; clinical outcomes assessed up to 90 days after discharge	Exploratory analysis of the association between non-invasive physiological signals recorded by the Acorai Device 1.0 during hospitalization (from informed consent until discharge) and the occurrence of the composite outcome of heart failure hospitalization or all-cause mortality.	Measurements collected from informed consent until hospital discharge; clinical outcomes assessed up to 90 days after discharge
Change in Non-Invasive Physiological Signals Recorded by the Acorai Device During Hospitalization Временное ограничение: From the time of informed consent until hospital up to 14 days	Exploratory evaluation of longitudinal changes in non-invasive physiological signals recorded by the Acorai Device 1.0 during daily measurements performed from informed consent through hospital discharge.	From the time of informed consent until hospital up to 14 days
Length of Index Hospitalization Временное ограничение: Through hospital discharge, up to 30 days	Duration of the index hospitalization measured as the number of days between hospital admission and hospital discharge	Through hospital discharge, up to 30 days

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Acorai AB

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 апреля 2026 г.

Первичное завершение (Оцененный)

1 марта 2027 г.

Завершение исследования (Оцененный)

1 апреля 2027 г.

Даты регистрации исследования

Первый отправленный

5 марта 2026 г.

Впервые представлено, что соответствует критериям контроля качества

23 июня 2026 г.

Первый опубликованный (Действительный)

26 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)