A Phase 2 interventional study of Immediate release torsemide 20mg tablet and Extended release torsemide 24mg tablet in Heart Failure, sponsored by Sarfez Pharmaceuticals, Inc.. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Sarfez Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
The goal of this randomized double-blind crossover study is to assess whether a morning dose of the extended release torsemide has a better efficacy than the ordinary immediate release torsemide to induce renal sodium excretion after a salty lunch in patients with stable heart failure. The main questions it aims to answer are:
Participants will be asked to:
Researchers will compare the amount of sodium excretion when each subject is taking immediate release torsemide versus the time that the same subject is taking extended release torsemide.
Sarfez Inc has developed an extended release formulation of torsemide, whose effect lasts for several hours after the dosing. The purpose of this study is to assess whether a morning dose of the extended release torsemide has a better efficacy than the ordinary immediate release torsemide to induce renal sodium excretion after a salty lunch.
This is a randomized double-blind crossover study of the patients with stable heart failure, who are on a stable dose of a loop diuretic. During the study period, the participants' loop diuretics will be replaced by the equivalent dose of immediate release/extended release torsemide and they will receive standardized meals throughout the study period. After a "week" of taking a morning dose of each of the two torsemide formulations, serial urinary sodium measurements following a salty lunch will be compared between the time that the subject was taking the immediate release vs. the time period that the subject was taking the extended release torsemide as a single morning dose.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
Browse Heart Failure studies →Sarfez Pharmaceuticals, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Immediate release torsemide 20mg tablet · Drug: Extended release torsemide 24mg tablet
Drug: Immediate release torsemide 20mg tablet · Drug: Extended release torsemide 24mg tablet
Subjects will receive approximately one week of daily immediate release 20mg torsemide (plus daily placebo of 24mg extended release torsemide) and one week of daily extended release 24mg torsemide (plus daily placebo of 20mg immediate release torsemide) with no gap in between. Subjects will be randomly assigned to immediate-release torsemide-first arm versus extended-release torsemide-first arm and at the end of the initial one-week period, they will be switched to the other intervention. Subjects will consume only the provided meals with standardized amount of sodium content throughout the study period.
Subjects will receive approximately one week of daily immediate release 20mg torsemide (plus daily placebo of 24mg extended release torsemide) and one week of daily extended release 24mg torsemide (plus daily placebo of 20mg immediate release torsemide) with no gap in between. Subjects will be randomly assigned to immediate-release torsemide-first arm versus extended-release torsemide-first arm and at the end of the initial one-week period, they will be switched to the other intervention. Subjects will consume only the provided meals with standardized amount of sodium content throughout the study period.
Cumulative Na+ excretion over 6 hours
The primary outcome is the cumulative Na+ excretion over 6 hours after lunch.
Time frame: 6 hours after lunch
Fluid and Na+ excretion over the 6 hours
Fluid and Na+ excretion over the 6 hours after breakfast, 6 hours after lunch, and 24 hours after dosing.
Time frame: 6 hours after breakfast, 6 hours after lunch, and 24 hours
creatinine clearance
Safety outcome
Time frame: While in the study (approximately 2 weeks)
K+ excretion
Safety outcome
Time frame: While in the study (approximately 2 weeks)
Ran from Nov 2024 to primary completion in Mar 2025, 4 months.
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This study is withdrawn, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Sarfez Pharmaceuticals, Inc.