NCT06898515

Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)

Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Reprieve Cardiovascular, Inc · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve 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 System can more efficiently decongest ADHF patients in comparison to Control Therapy.

Conditions

• Acute Decompensated Heart Failure

Interventions

Type	Name	Description
DEVICE	Reprieve System	The Reprieve System 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	furosemide infusion	Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy

Timeline

• Start date: 2025-07-14
• Primary completion: 2027-08-01
• Completion: 2027-12-01
• First posted: 2025-03-27
• Last updated: 2025-11-26

Locations

53 sites across 5 countries: United States, Germany, Italy, Poland, Spain

Regulatory

• FDA-regulated device study