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Hemodynamic Observational Study in Patients With Heart Failure Using a Non-Invasive Multi-Modal Sensing Device (HOSP-HF)

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Skåne University Hospital
RECRUITING
Lund
Contact Information
Primary
Warka AlHassani
warka.alhassani@acorai.com
+46 709 72 60 97
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 1000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Acorai AB

This content was sourced from clinicaltrials.gov