Non-Invasive Hemodynamic Monitoring in Hospitalized Heart Failure
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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Warka AlHassani
- Número de telefone: +46 709 72 60 97
- E-mail: warka.alhassani@acorai.com
Locais de estudo
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Lund, Suécia
- Recrutamento
- Skane University Hospital
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Contato:
- Oscar Braun
- Número de telefone: +46 46 17 36 90
- E-mail: oscar.braun@med.lu.se
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Composite of 90-Day Heart Failure Hospitalization or All-Cause Mortality
Prazo: 90 days after discharge from the index hospitalization
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Occurrence of either heart failure hospitalization or death from any cause within 90 days following the index hospitalization.
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90 days after discharge from the index hospitalization
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Association Between Non-Invasive Physiological Signals Recorded by the Acorai Device and 90-Day Clinical Outcomes
Prazo: Measurements collected from informed consent until hospital discharge; clinical outcomes assessed up to 90 days after discharge
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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.
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Measurements collected from informed consent until hospital discharge; clinical outcomes assessed up to 90 days after discharge
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Change in Non-Invasive Physiological Signals Recorded by the Acorai Device During Hospitalization
Prazo: From the time of informed consent until hospital up to 14 days
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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.
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From the time of informed consent until hospital up to 14 days
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Length of Index Hospitalization
Prazo: Through hospital discharge, up to 30 days
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Duration of the index hospitalization measured as the number of days between hospital admission and hospital discharge
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Through hospital discharge, up to 30 days
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HOSP-HF
Plano para dados de participantes individuais (IPD)
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