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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: Hospitalized Heart Failure Patients
Trial outcomes
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.
Time frame
90 days after discharge from the index hospitalizationOther outcomes
1
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.
Time frame
Measurements collected from informed consent until hospital discharge; clinical outcomes assessed up to 90 days after discharge2
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.
Time frame
From the time of informed consent until hospital up to 14 days3
Length of Index Hospitalization
Duration of the index hospitalization measured as the number of days between hospital admission and hospital discharge
Time frame
Through hospital discharge, up to 30 days Source ClinicalTrials.gov