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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT03586336
Status
Recruiting

Conditions

  • Heart Failure; With Decompensation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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

Key Dates

First listed
Jul 13, 2018
Start date
Dec 1, 2018
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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%.
  • 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

Primary Outcome Measure

Net Fluid Balance during hospitalization [ Time Frame: During hospitalization, approximately 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Cassie Nguyen
415-353-9124
Liviu Klein, M.D.
415-476-2143

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