Comparison of Once Daily 40 mg Torsemide With Twice-daily 40 mg Furosemide

NCT03509545 — Phase 1, Terminated, 20 participants, Sarfez Pharmaceuticals, Inc.

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An Open Label,Crossover Study to Compare Once Daily Dose of 40 mg Torsemide Extended Release to Twice Daily of Furosemide on Natriuresis and Body Weight in Congestive Heart Failure (CHF) Patients Who Are on Stable Dose of Furosemide

Registry	NCT03509545
Status	Terminated - recruitment issues
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	20 (Actual)
Sponsor	Sarfez Pharmaceuticals, Inc. (Industry)
Conditions	Body Weight Changes
Interventions	CHF Patients: ER Torsemide 40 mg, CHF Patients: Furosemide 40 mg (Drug)
Dates	start 2021-06-30, primary completion 2022-06-30, completion 2022-06-30, first posted 2018-04-26, last updated 2026-04-24
Locations	1 site in India

-Summary

To compare the effects of 40 mg once-daily Torsemide ER to 40 mg twice daily Furosemide on 24-hour sodium excretion.

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+Detailed description

To compare the effects of 40 mg once-daily Torsemide ER to 40 mg twice-daily Furosemide on changes in body weight after two weeks of treatment. To compare the frequency and volume of urine passed in 24 hours. To compare the patients' quality of life and levels of natriuretic peptide between the two sets of patients.

+Arms and interventions

Arm	Type	Interventions	Description
CHF Patients: ER Torsemide 40 mg	Experimental	Drug: CHF Patients: ER Torsemide 40 mg	CHF patients will be given 40 mg ER Torsemide
CHF Patients: Furosemide 40 mg	Active comparator	Drug: CHF Patients: Furosemide 40 mg	CHF patients are on 40 mg of Furosemide

CHF Patients: ER Torsemide 40 mg (Drug), also known as Demadex: ER Torsemide 40mg given once daily to CHF patients
CHF Patients: Furosemide 40 mg (Drug), also known as Lasix: Stable CHF patients taking twice-daily 40 mg Furosemide

+Outcome measures

Primary outcomes

change in 24-hour sodium excretion compared to baseline [24 hours]: the difference in 24 hour sodium excretion between ER Torsemide and Furosemide

Secondary outcomes

Changes in body weight [2 weeks]: Body weight changes will be compared between the two arms

+Eligibility

Sex: Male, ages: 18 Years to 70 Years

Inclusion Criteria:

* Patients of either gender over 18 years of age with clinical diagnosis of CHF and on a stable dose of 40 mg Furosemide.

Exclusion Criteria:

* Requirement for any other diuretic, history of cardiac dysrhythmia, other concurrent cardiovascular illness.

+Locations (1)

Facility	City	Country	Status
Syngene International	Bangalore, Karnataka	India

+Investigators

Anil K, MD, Principal investigator, Syngene