Non-Invasive Hemodynamic Monitoring in Hospitalized Heart Failure

NCT07671742 | Recruiting

• 1 other identifier: HOSP-HF
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Heart Failure Hospitalization; Heart Failure (HF)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Association Between Non-Invasive Physiological Signals Recorded by the Acorai Device and 90-Day Clinical Outcomes

  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

  From the time of informed consent until hospital up to 14 days

• Length of Index Hospitalization

  Through hospital discharge, up to 30 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acorai AB: lead

Study Sites (1)

Skåne University Hospital

Lund, Sweden

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Warka AlHassani

CONTACT

+46 709 72 60 97; warka.alhassani@acorai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: June 26, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

SE (1)