Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Liviu Klein, MD, MS
Headshot of Liviu Klein
Liviu Klein

Description

Summary

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

Official Title

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

Details

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.

Keywords

Heart Failure; With Decompensation, Heart Failure, ReDS-Guided

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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%

You CAN'T join if...

  • 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)

Location

  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Liviu Klein, MD, MS
    My are heart failure and cardiac arrhythmias in patients with heart failure. Having advanced training in both heart failure and electrophysiology, I practice an integrated approach in treating patients with heart failure and cardiac arrhythmias. I am also interested in cardiac recovery using electrical (i.e. cardiac resynchronization) and mechanical (i.e. ventricular assist devices) therapies.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03586336
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated