NCT06708611

A Crossover Study of Patients with HF to Compare Natriuretic Effects of IR Torsemide Vs. ER Torsemide Over 12 Hrs

A Crossover Study to Compare Natriuretic Effects of Extended Release Torsemide to Immediate Release Torsemide Over 12 Hours After Dosing in Patients with Heart Failure (EXTOR-HF)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Sarfez Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized double-blind crossover study of the patients with stable heart failure, who are taking a loop diuretic. During the study period, the participants' loop diuretics will be replaced by the equivalent dose of immediate release/extended release torsemide for one week. After a one week period, they will report to the site and will receive a single dose of either immediate release or extended release Torsemide. The sodium excretion will be measured for six hours after dosing and for an additional six hours after a high salt lunch.

Detailed description

The goal of this randomized double-blind crossover study is to assess whether extended release torsemide has a better efficacy than immediate release torsemide to induce renal sodium excretion after a salty lunch in patients with heart failure. The study will address if: * the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a morning dose of extended release torsemide is different from the amounts after the immediate release torsemide. * the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, is different from the amounts after the immediate release torsemide. * the amount of excreted sodium in the urine during the 24 hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, is different from the amount after the immediate release torsemide.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	torsemide	Extended release formulation of torsemide

Timeline

• Start date: 2025-01-15
• Primary completion: 2025-03-25
• Completion: 2025-03-25
• First posted: 2024-11-27
• Last updated: 2025-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study