Non-Invasive Hemodynamic Monitoring in Hospitalized Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcorai AB
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov