drugset / Trial / NCT06362668
EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU)
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-05-17
- Primary completion
- 2024-10-01
- Completion
- 2024-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetazolamide | Small molecule | — | — |
| Comparator | Bumetanide | Small molecule | — | — |
| Comparator | Furosemide | Other / unclassified | — | — |
| Comparator | Hydrochlorothiazide | Unknown | — | — |
| Comparator | Torsemide | Other / unclassified | — | — |