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Comparing Natriuretic Effects of ER Torsemide to IR Torsemide in Patients With Heart Failure
Sponsor: Sarfez Pharmaceuticals, Inc.
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.
Official title: A Randomized, Two-Period, Two-Arm, Double-Dummy, Crossover Study to Compare Natriuretic Effects of Extended Release Torsemide to Immediate Release Torsemide in Patients With Heart Failure (NEXT-HF)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
0
Start Date
2025-05
Completion Date
2026-09-16
Last Updated
2026-09-28
Healthy Volunteers
No
Interventions
Extended Release Torsemide Tablets
Extended release torsemide vs Immediate release torsemide
Immedate Release Torsemide Tablets
Immediate release torsemide vs Extended release torsemide
Locations (1)
Future Life Clinical Trials
Miami, Florida, United States