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

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Heart Failure; With Decompensation

Treatments: Device: Usual Care; Device: ReDS-Guided

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03586336

RADAR-HF

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

ReDS-Guided

Experimental group

Description:

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%.

Treatment:

Device: ReDS-Guided

Control

Sham Comparator group

Description:

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

Treatment:

Device: Usual Care