NCT03586336

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure; With Decompensation

Interventions

Type	Name	Description
DEVICE	ReDS-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
DEVICE	Usual Care	ReDS measurements will not be shared with the treating clinicians, who will guide diuresis using standard clinical criteria

Timeline

• Start date: 2018-12-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2018-07-13
• Last updated: 2022-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study