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

Heart Failure; With Decompensation Clinical Trial

— RADAR-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03586336
• Other study ID #: RADAR-HF
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2022
• Source: University of California, San Francisco
• Contact: Cynthia Partida-Higuera
• Phone: 415-514-1125
• Email: Cynthia.Partida-Higuera[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure; With Decompensation

Intervention

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
• Usual Care
ReDS measurements will not be shared with the treating clinicians, who will guide diuresis using standard clinical criteria

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Sensible Medical Innovations Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Length of Stay in hospital	Duration of hospitalization	During hospitalization, approximately 7 days
Secondary	Major adverse cardiac events at 30 days	The combined rate of cardiovascular mortality or heart failure readmission at 30 days	30 Days after discharge