Clinical Evidence
100 Patient Pilot Randomized Control Trial
Fluid management of Acute decompensated heart failure Subjects Treated with Reprieve System
The FASTR pilot trial was a multicenter, randomized, controlled trial designed to evaluate the efficacy and safety of the Reprieve Therapy in optimizing decongestion in ADHF patients. The trial enrolled a total of 100 patients, 96 of whom were randomized 1:1 to receive treatment with the Reprieve Therapy or optimal diuretic treatment based on best-practice dosing.
Key Results from FASTR
With traditional diuresis, clinicians often face a trade-off
Aggressive Decongestion
Patient Safety
IN THE FASTR PILOT, REPRIEVE THERAPY DEMONSTRATED
✓Faster decongestion with no difference in safety events.
✓No difference in change in creatinine.
Primary safety composite: 16 events in Reprieve vs 19 events in ODT (p=0.42)
~2×
Faster IV diuretic completion¹46 hrs with Reprieve vs 88 hrs with ODT (P = 0.014)
Faster IV diuretic completion¹
46 hrs with Reprieve vs 88 hrs with ODT (P = 0.014)
~40%
More weight loss²3.8 ± 1.8 kg/24h with Reprieve vs 2.7 ± 2.8 kg with Control (P = 0.002)
More weight loss²
3.8 ± 1.8 kg/24h with Reprieve vs 2.7 ± 2.8 kg with Control (P = 0.002)
~35%
Higher sodium excretion²587 ± 303 mmol/24h with Reprieve vs 436 ± 317 mmol with Control (P = < 0.001)
Higher sodium excretion²
587 ± 303 mmol/24h with Reprieve vs 436 ± 317 mmol with Control (P = < 0.001)
Pivotal Trial -- NOW ENROLLING
Overview
FASTR II (Fluid Management of ADHF Subjects Treated with Reprieve) is a randomized,
controlled pivotal trial in the United States and Europe.
The study will compare outcomes between patients receiving guided decongestive therapy with
the Reprieve System and those receiving optimal standard care (conventional diuretic therapy).
Key endpoints include the amount of fluid and sodium removed within 24 hours, kidney function
measures, and patient outcomes such as length of stay and readmissions.
