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

NCT03586336 | Unknown FDA Device

• 1 other identifier: RADAR-HF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure; With Decompensation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in GFR from admission to discharge

  During hospitalization, approximately 7 days

• Length of Stay in hospital

  During hospitalization, approximately 7 days

• Major adverse cardiac events at 30 days

  30 Days after discharge

Study Arms (2)

ReDS-Guided

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Interventions

ReDS-Guided DEVICE

ReDS measurements will be shared with the treating clinicians who can use the information to guide diuresis and determine the appropriate timing of discharge

ReDS-Guided

Usual Care DEVICE

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• Sensible Medical Innovations Ltd.: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Publications (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.

  PMID: 19215829 BACKGROUND

• 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.

  PMID: 28341372 BACKGROUND

• 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.

  PMID: 23350643 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Liviu Klein, MD, MS

  Director, Mechanical Circulatory Support and Heart Failure Device Program

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Partida-Higuera

CONTACT

415-514-1125; Cynthia.Partida-Higuera@ucsf.edu

Liviu Klein, MD, MS

CONTACT

415-476-2143; liviu.klein@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 13, 2018
• Study Start: December 1, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)