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WITHDRAWN
NCT06995144
PHASE4

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

Sponsor: Sarfez Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

DRUG

Extended Release Torsemide Tablets

Extended release torsemide vs Immediate release torsemide

DRUG

Immedate Release Torsemide Tablets

Immediate release torsemide vs Extended release torsemide

Locations (1)

Future Life Clinical Trials

Miami, Florida, United States