San Francisco, California 94143


Purpose:

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


Study summary:

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.


Criteria:

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)


NCT ID:

NCT03586336


Primary Contact:

Principal Investigator
Liviu Klein, MD, MS
Director, Mechanical Circulatory Support and Heart Failure Device Program

Evan Whitehead, B.A.
Phone: 408-550-3142
Email: evan.whitehead@ucsf.edu


Backup Contact:

Email: liviu.klein@ucsf.edu
Liviu Klein, MD, MS
Phone: 415-476-2143


Location Contact:

San Francisco, California 94143
United States

Evan Whitehead, B.A.
Phone: 408-550-3142
Email: evan.whitehead@ucsf.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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