drugset / Trial / NCT06362668

EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU)

NCT06362668

Completed 12 enrolled Reprieve Cardiovascular, Inc
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

EvaluationDrugModalityDoseRoute
Comparator Acetazolamide Small molecule
Comparator Bumetanide Small molecule
Comparator Furosemide Other / unclassified
Comparator Hydrochlorothiazide Unknown
Comparator Torsemide Other / unclassified

Indications