drugset / Trial / NCT06995144

Comparing Natriuretic Effects of ER Torsemide to IR Torsemide in Patients With Heart Failure

NCT06995144

Phase 4 Completed 20 enrolled Sarfez Pharmaceuticals, Inc.
RandomizedCrossoverQuadruple-blindTreatment

Summary

The primary objective of this study is to learn whether a morning dose of extended-release torsemide enhances renal sodium excretion after lunch (4-8 hours after dosing) compared to immediate-release torsemide. This is a randomized, double-blind, crossover study in patients with heart failure who are on a stable dose of a loop diuretic. The primary endpoint will be urinary sodium excretion (4-8 hours after dosing). This will be compared between the extended-release arm and the immediate-release arm to assess the efficacy of prolonged diuretic action. In addition, urinary potassium and creatinine excretion and creatinine clearance will be measured in all urine samples as the safety endpoints.

Timeline

Start
2025-05-28
Primary completion
2025-12-30
Completion
2025-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Torsemide Other / unclassified 20 mg
Comparator Torsemide Other / unclassified 24 mg
Comparator Torsemide Other / unclassified 40 mg
Comparator Torsemide Other / unclassified 48 mg

Indications