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.
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Warka AlHassani
- Numéro de téléphone: +46 709 72 60 97
- E-mail: warka.alhassani@acorai.com
Lieux d'étude
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Lund, Suède
- Recrutement
- Skane University Hospital
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Contact:
- Oscar Braun
- Numéro de téléphone: +46 46 17 36 90
- E-mail: oscar.braun@med.lu.se
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Composite of 90-Day Heart Failure Hospitalization or All-Cause Mortality
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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Association Between Non-Invasive Physiological Signals Recorded by the Acorai Device and 90-Day Clinical Outcomes
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HOSP-HF
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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