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NCT Number: NCT03586336

Remote Dielectric Sensing (ReDS) Assisted Diuresis in 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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Usual Care

Device

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

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Partida-Higuera

CONTACT

[email protected]

415-514-1125

Liviu Klein, MD, MS

CONTACT

[email protected]

415-476-2143

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Sensible Medical Innovations Ltd.

Registry information

Official study title

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

Acronym: RADAR-HF

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2018
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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