drugset / Trial / NCT06995144

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

NCT06995144 ↗

Phase 4 Withdrawn Sarfez Pharmaceuticals, Inc.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
Primary completion
2026-09-16
Completion
2026-09-16

Outcome

Outcome not reported

Stopped (Enrollment): “No participants enrolled”

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