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Non-Invasive Hemodynamic Monitoring in Hospitalized Heart Failure

23 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

1000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Zweden
      • Lund, Zweden
        • Werving
        • Skane University Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Composite of 90-Day Heart Failure Hospitalization or All-Cause Mortality
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Association Between Non-Invasive Physiological Signals Recorded by the Acorai Device and 90-Day Clinical Outcomes
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Acorai AB

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 april 2026

Primaire voltooiing (Geschat)

1 maart 2027

Studie voltooiing (Geschat)

1 april 2027

Studieregistratiedata

Eerst ingediend

5 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2026

Eerst geplaatst (Werkelijk)

26 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

23 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HOSP-HF

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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