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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03586336
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : June 17, 2020
Sponsor:
Collaborator:
Sensible Medical Innovations Ltd.
Information provided by (Responsible Party):
University of California, San Francisco

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

Condition or disease Intervention/treatment Phase
Heart Failure; With Decompensation Device: ReDS-Guided Device: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Remote Dielectric Sensing Technology Guided Diuresis in Hospitalized Patients With Acute Decompensated Heart Failure
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. Net Fluid Balance during hospitalization [ Time Frame: During hospitalization, approximately 7 days ]
    Cumulative net fluid balance assessed by In's and Out's recorded in the Electronic Medical Record (EMR) during hospitalization


Secondary Outcome Measures :
  1. Change in GFR from admission to discharge [ Time Frame: During hospitalization, approximately 7 days ]
    Net change in GFR (calculated using the Chronic Kidney Disease Epidemiology 2009 equation) from admission to discharge

  2. Length of Stay in hospital [ Time Frame: During hospitalization, approximately 7 days ]
    Duration of hospitalization

  3. Major adverse cardiac events at 30 days [ Time Frame: 30 Days after discharge ]
    The combined rate of cardiovascular mortality or heart failure readmission at 30 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586336


Contacts
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Contact: Evan Whitehead, B.A. 408-550-3142 evan.whitehead@ucsf.edu
Contact: Liviu Klein, MD, MS 415-476-2143 liviu.klein@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Crystal Tse, BA    415-514-7280    Crystal.Tse@ucsf.edu   
Contact: Liviu Klein, M.D.    415-476-2143    liviu.klein@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Sensible Medical Innovations Ltd.
Investigators
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Principal Investigator: Liviu Klein, MD, MS Director, Mechanical Circulatory Support and Heart Failure Device Program
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03586336    
Other Study ID Numbers: RADAR-HF
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases