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

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

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; With Decompensation
• Intervention / Treatment: Device: ReDS-Guided; Device: Usual Care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cynthia Partida-Higuera; Phone Number: 415-514-1125; Email: Cynthia.Partida-Higuera@ucsf.edu
• Study Contact Backup: Name: Liviu Klein, MD, MS; Phone Number: 415-476-2143; Email: liviu.klein@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Cassie Nguyen; Phone Number: 415-353-9124; Email: cassie.nguyen@ucsf.edu
      • Contact: Liviu Klein, M.D.; Phone Number: 415-476-2143; Email: liviu.klein@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ReDS-Guided; 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%.	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
Sham Comparator: Control; 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	Device: Usual Care; ReDS measurements will not be shared with the treating clinicians, who will guide diuresis using standard clinical criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net Fluid Balance during hospitalization	Cumulative net fluid balance assessed by In's and Out's recorded in the Electronic Medical Record (EMR) during hospitalization	During hospitalization, approximately 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in GFR from admission to discharge	Net change in GFR (calculated using the Chronic Kidney Disease Epidemiology 2009 equation) from admission to discharge	During hospitalization, approximately 7 days
Length of Stay in hospital	Duration of hospitalization	During hospitalization, approximately 7 days
Major adverse cardiac events at 30 days	The combined rate of cardiovascular mortality or heart failure readmission at 30 days	30 Days after discharge

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Sensible Medical Innovations Ltd.
• Investigators: Principal Investigator: Liviu Klein, MD, MS, Director, Mechanical Circulatory Support and Heart Failure Device Program

Publications and helpful links

General Publications

• Amir O, Rappaport D, Zafrir B, Abraham WT. A novel approach to monitoring pulmonary congestion in heart failure: initial animal and clinical experiences using remote dielectric sensing technology. Congest Heart Fail. 2013 May-Jun;19(3):149-55. doi: 10.1111/chf.12021. Epub 2013 Jan 25.
• Amir O, Ben-Gal T, Weinstein JM, Schliamser J, Burkhoff D, Abbo A, Abraham WT. Evaluation of remote dielectric sensing (ReDS) technology-guided therapy for decreasing heart failure re-hospitalizations. Int J Cardiol. 2017 Aug 1;240:279-284. doi: 10.1016/j.ijcard.2017.02.120. Epub 2017 Mar 3.
• Gheorghiade M, Pang PS. Acute heart failure syndromes. J Am Coll Cardiol. 2009 Feb 17;53(7):557-573. doi: 10.1016/j.jacc.2008.10.041.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: June 13, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: RADAR-HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No