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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Heart Failure (HF); Heart Failure Hospitalization

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Warka AlHassani; Phone Number: +46 709 72 60 97; Email: warka.alhassani@acorai.com

Study Locations

• Sweden
  • Lund, Sweden
    • Recruiting
    • Skane University Hospital
    • Contact: Oscar Braun; Phone Number: +46 46 17 36 90; Email: oscar.braun@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of 90-Day Heart Failure Hospitalization or All-Cause Mortality	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association Between Non-Invasive Physiological Signals Recorded by the Acorai Device and 90-Day Clinical Outcomes	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	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	Duration of the index hospitalization measured as the number of days between hospital admission and hospital discharge	Through hospital discharge, up to 30 days

Collaborators and Investigators

• Sponsor: Acorai AB

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: HOSP-HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No