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
Conditions:
🦠 Heart Failure; With Decompensation
🗓️ Study Start (Actual) 1 December 2018
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 San Francisco, California, United States

📋 Eligibility Criteria

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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 June 2018
  • First Submitted that Met QC Criteria 2 July 2018
  • First Posted 13 July 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 November 2022
  • Last Update Posted 1 December 2022
  • Last Verified November 2022