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 — DEVICEReDS 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 — DEVICEReDS 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-GuidedPatients 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: ControlPatients 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
- Cynthia Partida-Higuera415-514-1125
- Liviu Klein, MD, MS415-476-2143
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 |
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