Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
furosemide infusion: Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy
Study 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.
Eligibility
Primary outcome measure(s)
- Hierarchical composite/win-ratio — 1. up to 30 days from randomization, 2. up to 30 days from discharge, 3. up to 72 hours after randomization
1. Freedom from 30-day CV mortality 2. Freedom from HF Rehospitalization 30 days post-discharge 3. Greater net sodium loss per 24 hours during treatment - Incidence of device/procedure-related adverse events (KDIGO stage 2 or greater AKI, CAUTI) — initiation of randomized therapy through 72 hours following completion of randomized therapy
KDIGO stage 2 or greater AKI: ≥ doubling of serum creatinine or use of renal replacement therapy; CAUTI per CDC definition
Trial sites (50)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California Irvine | Irvine | California | Recruiting |
| Memorial Care Long Beach | Long Beach | California | Recruiting |
| UC Davis Medical Center | Sacramento | California | Recruiting |
| University of Florida | Gainesville | Florida | Recruiting |
| Piedmont Atlanta Hospital | Atlanta | Georgia | Recruiting |
| Wellstar Hospital | Atlanta | Georgia | Recruiting |
| Piedmont Augusta Hospital | Augusta | Georgia | Recruiting |
| Northeast Georgia Medical Center | Gainesville | Georgia | Recruiting |
| Advocate Christ Medical Center | Oak Lawn | Illinois | Not Yet Recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | Recruiting |
| University of Louisville Hospital | Louisville | Kentucky | Recruiting |
| Trinity Health Ann Arbor Hospital | Ann Arbor | Michigan | Recruiting |
| Corewell Health Butterworth Hospital | Grand Rapids | Michigan | Recruiting |
| Corewell William Beaumont University Hospital | Royal Oak | Michigan | Recruiting |
| Minneapolis Heart Institute | Minneapolis | Minnesota | Recruiting |
| University of Mississippi | Jackson | Mississippi | Recruiting |
| St. Louis VA | St Louis | Missouri | Recruiting |
| Washington University | St Louis | Missouri | Recruiting |
| Duke University | Durham | North Carolina | Recruiting |
| Moses H. Cone Memorial Hospital | Greensboro | North Carolina | Recruiting |
| Atrium Health Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | Recruiting |
| Lindner Center at Christ Hospital | Cincinnati | Ohio | Recruiting |
| UH Cleveland Medical Center | Cleveland | Ohio | Recruiting |
| Ohio State University Hospital | Columbus | Ohio | Recruiting |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| Prisma Health Greenville Memorial Hospital | Greenville | South Carolina | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Recruiting |
| Baylor Scott and White | Dallas | Texas | Recruiting |
| Baylor College of Medicine Ben Taub Hospital | Houston | Texas | Recruiting |
| Houston Methodist | Houston | Texas | Recruiting |
| Memorial Hermann-Texas Medical Center | Houston | Texas | Recruiting |
| Inova Fairfax Medical Campus | Falls Church | Virginia | Recruiting |
| VCU Medical Center | Richmond | Virginia | Recruiting |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | Recruiting |
| Universitätsklinikum Gießen (UKGM) | Giessen | Germany | Recruiting |
| Hannover University Hospital | Hanover | Germany | Recruiting |
| University Hospital Heidelberg | Heidelberg | Germany | Recruiting |
| Universitaria delle Marche | Ancona | Italy | Recruiting |
| ASST Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | Italy | Recruiting |
+ 10 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06898515 on ClinicalTrials.gov ↗ ← All trials in Italy