BENITIONSClinical Trial Intelligence

Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS)

N/A Completed NCT05174312

ConditionAcute Decompensated Heart Failure
PhaseN/A
SponsorReprieve Cardiovascular, Inc
StatusCompleted
Enrollment100 participants
InterventionsReprieve Decongestion Management System, Diuretic
Start dateJul 11, 2022
Completion dateJan 10, 2025
Results postedMay 29, 2026

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 can more efficiently decongest ADHF patients in comparison to Control Therapy.

Total Urine Sodium Output

24 hours post-treatment initiation · mmol of sodium

Reprieve Decongestion Management System1082 ± 487 mmol of sodium
Optimal Diuretic Therapy423 ± 290 mmol of sodium
p-value<0.001

Clinically Significant Acute Kidney Injury, Severe Electrolyte Abnormality, Symptomatic Hypotension or Hypertensive Emergency.

End of treatment, 0-72 hours. · total number of events

Reprieve Decongestion Management System16 total number of events
Optimal Diuretic Therapy19 total number of events
p-value0.43

Open in BENITIONS View on ClinicalTrials.gov

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