Comparing Reprieve System Device to Standard Diuretic Therapy for Treating Acute Decompensated Heart Failure in Adults

What this Trial Is About

Researchers are evaluating the effectiveness of the Reprieve System compared to Optimal Diuretic Therapy ODT in treating patients with acute decompensated heart failure ADHF. The study aims to find out if the Reprieve System can decongest patients more efficiently than current standard therapy. This is a phase 3 clinical trial sponsored by Reprieve Cardiovascular, Inc. Participants will be randomly assigned to one of three groups receiving treatment with the Reprieve System device, undergoing ODT with guided diuretic titration following ESC guidelines, or receiving usual care at the local site. The Reprieve System delivers personalized and automated infusions of the IV diuretic furosemide and saline based on real-time urine output. Treatments are monitored through the hospital stay, with average discharge readiness occurring around 5 days. During the study, participants will be closely monitored for fluid and sodium loss, weight changes, time on intravenous diuretics, and hospital length of stay. Researchers will also track heart failure rehospitalizations and cardiovascular mortality up to 90 days after discharge. Safety assessments include checking for adverse events like kidney injury, infections, electrolyte imbalances, and other complications. The total participation period includes hospital treatment and follow-up assessments extending up to three months after discharge.

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