Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS)
NCT05174312 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-07-24
Summary
The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve DMS can more efficiently decongest ADHF patients in comparison to Control Therapy.
Conditions
- Acute Decompensated Heart Failure
Interventions
- DEVICE
-
Reprieve Decongestion Management System
The Reprieve Decongestion Management System, or Reprieve DMS, is a hospital bedside fluid management console designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure.
- DRUG
-
Diuretic
Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC).
Sponsors & Collaborators
-
Reprieve Cardiovascular, Inc
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-11
- Primary Completion
- 2025-01-10
- Completion
- 2025-01-10
- FDA Device
- Yes
Countries
- United States
Study Locations
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