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

Phase 4

Terminated

• Conditions: Heart Failure
• Interventions: Drug: torsemide

• Registration Number: NCT06708611
• Lead Sponsor: Sarfez Pharmaceuticals, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-11-24
• Study First Posted: 2024-11-27
• Study Start: 2025-01-15
• Status Verified: 2025-03
• Primary Completion: 2025-03-25
• Study Completion: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Man or woman over the age of 18 years.
• Willing and able to sign the informed consent.
• A clinical diagnosis of chronic HF that is considered by patient's cardiologist/physician or an experienced clinician to be stable over the one-month period prior to randomization.
• Receiving oral furosemide (or equivalent doses of torsemide or bumetanide) for about 30 days prior to randomization.
• No anticipated changes in HF medications during the study period.
• Premenopausal women of child-bearing potential have a negative pregnancy test prior to beginning of the study and agree to use effective contraceptive methods during the study period

Exclusion Criteria

• Requirement for a diuretic other than furosemide, bumetanide or torsemide except for spironolactone, eplerenone, finerenone, or SGLT2 inhibitors, at randomization and during the study.
• Myocardial infarction, stroke, transient ischemic attack, acute kidney injury or acute HF requiring admission to hospital within the last 30 days prior to randomization.
• Severe / symptomatic lung disease or respiratory symptoms distinct from HF.
• Urinary incontinence or inability to empty bladder.
• Uncontrolled diabetes mellitus or uncontrolled hypertension.
• Estimated GFR < 30 ml/min/1.72m2.
• History of flash pulmonary edema or amyloid cardiomyopathy.
• Female patients who are breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Extended release torsemide	torsemide	Drug: Extended release torsemide 24 mg tablet. Subjects will receive oral dose of 24 mg extended release torsemide tablet and a placebo of 20 mg immediate release torsemide.
Immediate release torsemide	torsemide	Drug: Immediate release torsemide 20 mg tablet. Subjects will receive oral dose of 20 mg of immediate release torsemide and a placebo of 24 mg extended release torsemide.

Primary Outcome Measures

Name	Time	Method
Cumulative Na+ excretion over 6 hours	6 hours after lunch	The primary outcome is the cumulative Na+ excretion over 6 hours after lunch.

Secondary Outcome Measures

Name	Time	Method
K+ excretion	While in the study (approximately 2 weeks)	Safety outcome
Fluid and Na+ excretion over the 6 hours	6 hours after breakfast, 6 hours after lunch, and 24 hours]	Fluid and Na+ excretion over the 6 hours after breakfast, 6 hours after lunch, and 24 hours after dosing.
Creatinine clearance	While in the study (approximately 2 weeks)	Safety outcome

Trial Locations

Locations (1)

Future Life Clinical Trials; 🇺🇸 Miami, Florida, United States