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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/12/2018
Start Date:December 1, 2018
End Date:May 1, 2019
Contact:Evan Whitehead, B.A.
Email:evan.whitehead@ucsf.edu
Phone:408-550-3142

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

This study evaluates the use of a wearable vest capable of non-invasively measuring lung
fluid content in hospitalized patients with heart failure

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.

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)

- Major cardiac event 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)
We found this trial at
1
site
San Francisco, California 94143
Phone: 408-550-3142
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from
San Francisco, CA
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