Remote Dielectric Sensing (ReDS) Assisted Diuresis in Acute Decompensated Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Remote Dielectric Sensing Technology Guided Diuresis in Hospitalized Patients With Acute Decompensated Heart Failure

Conditions
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Heart Failure; With Decompensation

Intervention / Treatment
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* Device: ReDS-Guided
* Device: Usual Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReDS-Guided<br>Patients in the intervention arm will undergo daily measurements of lung fluid content at the bedside with the ReDS vest. The values will be shared with the treating clinicians, who can use the measurements in addition to other standard data to guide diuresis. Patients should be discharged only once their lung fluid content falls within the normal range of 20-35%. | Device: ReDS-Guided<br>* ReDS measurements will be shared with the treating clinicians who can use the information to guide diuresis and determine the appropriate timing of discharge<br>|
| Sham Comparator: Control<br>Patients in the control arm will also undergo daily measurements of lung fluid content at the beside with the ReDS vest. However, the values will not be shared with the treating clinicians, who will direct management based on standard clinical tools | Device: Usual Care<br>* ReDS measurements will not be shared with the treating clinicians, who will guide diuresis using standard clinical criteria<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | During hospitalization, approximately 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in GFR from admission to discharge | Net change in GFR (calculated using the Chronic Kidney Disease Epidemiology 2009 equation) from admission to discharge | During hospitalization, approximately 7 days | 
| Length of Stay in hospital | Duration of hospitalization | During hospitalization, approximately 7 days | 
| Major adverse cardiac events at 30 days | The combined rate of cardiovascular mortality or heart failure readmission at 30 days | 30 Days after discharge |