drugset / Trial / NCT01863511

Tolvaptan/Ultrafiltration in the Treatment of Acute Heart Failure

NCT01863511

Phase 4 Completed 45 enrolled The Christ Hospital
RandomizedSingle-groupOpen-labelTreatment

Summary

For patients hospitalized with acute decompensated heart failure,volume removal remains the primary therapeutic objective. The current standard of care remains loop diuretics.The high likelihood of readmissions and poor outcomes highlights the need to examine and improve in-hospital protocols for these patients. Ultrafiltration allows for greater volume removal, less neurohormonal stimulation and greater sodium removal.However it is associated with increased costs, line complications, and relative immobility during treatment. Tolvaptan in addition to diuretic therapy has been shown to improve the amount of volume removed compared to diuretic alone. The study proposes to compare the strategy of adding tolvaptan to usual care with ultrafiltration as primary mode of therapy in acute decompensated HF(ADHF) patients. Hypothesis: addition of tolvaptan to usual care for hospitalized HF patients will result in: * greater volume and weight reduction compared with usual care * similar efficacy outcomes compared with ultrafiltration, with less complications of therapy

Timeline

Start
2013-05
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Furosemide Other / unclassified 10 mg Intravenous
Comparator Furosemide Other / unclassified 20 mg Intravenous
Comparator Tolvaptan Small molecule 30 mg Oral

Indications