This study evaluates the use of a wearable vest capable of non-invasively measuring lung fluid content in hospitalized patients with heart failure
Patients hospitalized for acute decompensated heart failure requiring treatment with intravenous diuretics and/or IV vasoactive drugs
Patient has signed informed consent and has authorized use and disclosed health information
Patient is at least 18 years of age
Patient physically suitable for ReDS measurement
Patient characteristics excluded from approved use of ReDS system: height less than 155cm or greater than 190cm, BMI <22 or >39, chest circumference <80cm or >115cm , or flail chest
Evidence of focal lung lesions on history, physical exam or chest x-ray, including history of pulmonary embolism, active pneumonia, or known lung nodule
Chronic renal failure (GFR<25)
Prior cardiac surgery within 2 months of index admission
Parallel
ReDS-Guided
DeviceReDS measurements will be shared with the treating clinicians who can use the information to guide diuresis and determine the appropriate timing of discharge
Usual Care
DeviceReDS measurements will not be shared with the treating clinicians, who will guide diuresis using standard clinical criteria
Net Fluid Balance during hospitalization
Cumulative net fluid balance assessed by In's and Out's recorded in the Electronic Medical Record (EMR) during hospitalization
Change in GFR from admission to discharge
Net change in GFR (calculated using the Chronic Kidney Disease Epidemiology 2009 equation) from admission to discharge
Length of Stay in hospital
Duration of hospitalization
Major adverse cardiac events at 30 days
The combined rate of cardiovascular mortality or heart failure readmission at 30 days
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University of California, San Francisco
Lead sponsor
Sensible Medical Innovations Ltd.
Collaborator
