Heart Failure; With Decompensation
Conditions
Brief summary
This study evaluates the use of a wearable vest capable of non-invasively measuring lung fluid content in hospitalized patients with heart failure
Detailed description
Inpatient management of acute decompensated heart failure centers around the efficient relief of congestion with IV diuretics and vasoactive agents. For the majority of patients, non-invasive, clinical bedside tools such as jugular venous pressure, pulmonary auscultation and daily weights are used to estimate cardiac filling pressures and guide diuresis. However, these methods are subject to significant inter-observer variability and can be unreliable for various reasons. Furthermore, recent studies have shown that overt signs of clinical congestion correlate poorly with hemodynamic congestion assessed by invasive means. Remote Dielectric Sensing is a novel technology that enables the non-invasive assessment of lung fluid content using a wearable vest. ReDS measurements have been shown to correlate with fluid status in hospitalized HF patients and have been used to remotely monitor ambulatory HF patients for signs of pre-clinical hemodynamic congestion. In this prospective, randomized study, we will assess the utility of ReDS guided diuresis in hospitalized patients with acute decompensated heart failure. All patients will receive daily ReDS measurements, but only treating physicians in the intervention group will be able to use these values to guide treatment.
Interventions
DEVICEReDS-Guided
ReDS measurements will be shared with the treating clinicians who can use the information to guide diuresis and determine the appropriate timing of discharge
DEVICEUsual Care
ReDS measurements will not be shared with the treating clinicians, who will guide diuresis using standard clinical criteria
Sponsors
University of California, San Francisco
Sensible Medical Innovations Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * GFR\>25 * Initial ReDS Measurement \>35%
Exclusion criteria
* 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 * Patient has a ventricular assist device or has had a cardiac transplantation * Patients in cardiogenic shock at admission requiring inotropic support * Congenital heart malformations or intra-thoracic mass that would affect right-lung anatomy (e.g dextrocardia, lung carcinoma, or pacemaker box in the right chest)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Fluid Balance during hospitalization | During hospitalization, approximately 7 days | Cumulative net fluid balance assessed by In's and Out's recorded in the Electronic Medical Record (EMR) during hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in GFR from admission to discharge | During hospitalization, approximately 7 days | Net change in GFR (calculated using the Chronic Kidney Disease Epidemiology 2009 equation) from admission to discharge |
| Length of Stay in hospital | During hospitalization, approximately 7 days | Duration of hospitalization |
| Major adverse cardiac events at 30 days | 30 Days after discharge | The combined rate of cardiovascular mortality or heart failure readmission at 30 days |
Countries
United States
Contacts
CONTACTCynthia Partida-Higuera
CONTACTLiviu Klein, MD, MS
PRINCIPAL_INVESTIGATORLiviu Klein, MD, MS
Director, Mechanical Circulatory Support and Heart Failure Device Program
Outcome results
None listed