NCT06362668

EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU)

EU Sites: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) (FASTR-EU)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Reprieve Cardiovascular, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence.

Conditions

• Acute Decompensated Heart Failure

Interventions

Type	Name	Description
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 (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide)	Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC).

Timeline

• Start date: 2024-05-17
• Primary completion: 2024-10-01
• Completion: 2024-10-31
• First posted: 2024-04-12
• Last updated: 2025-03-10

Locations

2 sites across 2 countries: Netherlands, Poland

Regulatory

• FDA-regulated device study