Heart FailurePhase 2NCT06176794
Immediate Release Torsemide Versus Extended Release Torsemide After Salty Meal
A Phase 2 study testing Immediate release torsemide 20mg tablet and Extended release torsemide 24mg tablet in people with Heart Failure, run by Sarfez Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Immediate release torsemide 20mg tablet and Extended release torsemide 24mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2024to 25 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 to be stable over the one-month period prior to randomization.
- Receiving a stable dose of furosemide of 40mg or 80mg total per day (or equivalent doses of torsemide or bumetanide) for at least 30 days prior to randomization.
- Optimum volume status determined by experienced physician.
- Able to consume a diet containing approximately 3 grams of Na+ daily.
- No anticipated changes in HF medications during the study period.
Who cannot join
- Requirement for a diuretic other than furosemide, bumetanide or torsemide except for spironolactone, eplerenone, finerenone, or SGLT2 inhibitors, given in stable dose for > 2 weeks before randomization and during the study.
- Known non-adherence to medication intake or salt restriction.
- 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 with a post-void residual volume >100 ml.
- Uncontrolled diabetes mellitus or uncontrolled hypertension.
Show all 11Show fewer
- Estimated GFR < 30 ml/min/1.72m2 of body surface area.
- Use of any non-loop diuretic in the last 30 days prior to randomization, with the exception of a low dose MRA (e.g., spironolactone of 25-50 mg per day) or an SGLT2 inhibitor.
- History of flash pulmonary edema or amyloid cardiomyopathy.
- Requirement for a non-steroidal anti-inflammatory drug other than low dose aspirin (<200 mg daily)
- Refusal or inability to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Nephrology, Hypertension & Renal Transplantation, University of Florida
Gainesville, Florida, 32610
About this study
Official title: A Crossover Study of Patients With Heart Failure to Compare Natriuretic Effects of Immediate Release Torsemide vs. Extended Release Torsemide Over 12 Hours After Dosing
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:
- Are the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a morning dose of extended release torsemide different from the amounts after the immediate release torsemide.
- Are 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, different from the amounts after the immediate release torsemide.
- Is 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, different from the amount after the immediate release torsemide.
Read more
Participants will be asked to:
- Start taking daily immediate release or extended release torsemide tablets that is provided to them.
- Eat the meals with standard contents of sodium that is provided to them and avoid other meals, drinks (except for water) and snacks for the duration of the study.
- Collect urine for 24 hours, after approximately one week of the initiation of the study medication.
- Go to the clinical research center the day that the 24-hour urine collection is finished and stay there throughout the day to receive standard meals and to have blood and urine samples collected.
- Switch torsemide pills to the new one that will be dispensed to them at the clinical research center. If they were taking the immediate release torsemide during the first part, then they will be given the sustained release torsemide and vice versa. The study is double blind; therefore, the subjects, study coordinators, and investigators are unaware of whether each subject is on immediate release torsemide first or on extended release torsemide first.
- Collect urine for an additional 12 hours after leaving the clinical research center to be sent to the clinical research center the next morning.
- Continue to take the provided meals and to avoid other meals, drinks (except for water) and snacks.
- Again, collect urine for 24 hours, after approximately one week, take that to the clinical research center when the 24-hour collection is completed and stay there throughout the day to receive standard meals and to have blood and urine samples collected.
- Collect urine for an additional 12 hours to be sent to the clinical research center the next morning.
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.
Read the detailed description
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.
- Conditions
- Heart Failure
- Being tested
- Immediate release torsemide 20mg tablet, Extended release torsemide 24mg tablet
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate release torsemide 20mg tabletDrug
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.
Extended release torsemide 24mg tabletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Extended release torsemide | Experimental | Not described Receives: Drug: Immediate release torsemide 20mg tablet; Drug: Extended release torsemide 24mg tablet |
| Immediate release torsemide | Active comparator | Not described Receives: Drug: Immediate release torsemide 20mg tablet; Drug: Extended release torsemide 24mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Na+ excretion over 6 hours
The primary outcome is the cumulative Na+ excretion over 6 hours after lunch.
Measured: 6 hours after lunch
Secondary outcomes (3)
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.
Measured: 6 hours after breakfast, 6 hours after lunch, and 24 hours
creatinine clearance
Safety outcome
Measured: While in the study (approximately 2 weeks)
K+ excretion
Safety outcome
Measured: While in the study (approximately 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start15 Nov 2024
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Why it stopped: Recruitment issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarfez Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Parta Hatamizadeh, MD, MPH, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176794
- Sponsor's protocol ID
- SAR065-224
- Other IDs
- GM0016563
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Study of Patients With Heart Failure to Compare Natriuretic Effects of Immediate Release Torsemide vs. Extended Release Torsemide Over 12 Hours After Dosing
- ClinicalTrials.gov ID
- NCT06176794
- Acronym / sponsor ID
- SAR065-224
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sarfez Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a morning dose of extended release torsemide different from the amounts after the immediate release torsemide.
- Are 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, different from the amounts after the immediate release torsemide.
- Is 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, different from the amount after the immediate release torsemide.
Participants will be asked to:
- Start taking daily immediate release or extended release torsemide tablets that is provided to them.
- Eat the meals with standard contents of sodium that is provided to them and avoid other meals, drinks (except for water) and snacks for the duration of the study.
- Collect urine for 24 hours, after approximately one week of the initiation of the study medication.
- Go to the clinical research center the day that the 24-hour urine collection is finished and stay there throughout the day to receive standard meals and to have blood and urine samples collected.
- Switch torsemide pills to the new one that will be dispensed to them at the clinical research center. If they were taking the immediate release torsemide during the first part, then they will be given the sustained release torsemide and vice versa. The study is double blind; therefore, the subjects, study coordinators, and investigators are unaware of whether each subject is on immediate release torsemide first or on extended release torsemide first.
- Collect urine for an additional 12 hours after leaving the clinical research center to be sent to the clinical research center the next morning.
- Continue to take the provided meals and to avoid other meals, drinks (except for water) and snacks.
- Again, collect urine for 24 hours, after approximately one week, take that to the clinical research center when the 24-hour collection is completed and stay there throughout the day to receive standard meals and to have blood and urine samples collected.
- Collect urine for an additional 12 hours to be sent to the clinical research center the next morning.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended release torsemide | Experimental | Drug: Immediate release torsemide 20mg tablet, Drug: Extended release torsemide 24mg tablet |
| Immediate release torsemide | Active comparator | Drug: Immediate release torsemide 20mg tablet, Drug: Extended release torsemide 24mg tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 to be stable over the one-month period prior to randomization.
- Receiving a stable dose of furosemide of 40mg or 80mg total per day (or equivalent doses of torsemide or bumetanide) for at least 30 days prior to randomization.
- Optimum volume status determined by experienced physician.
Key exclusion criteria (11 listed)
- Requirement for a diuretic other than furosemide, bumetanide or torsemide except for spironolactone, eplerenone, finerenone, or SGLT2 inhibitors, given in stable dose for > 2 weeks before randomization and during the study.
- Known non-adherence to medication intake or salt restriction.
- 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 with a post-void residual volume >100 ml.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate release torsemide 20mg tabletSubjects 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. | Drug | Extended release torsemide, Immediate release torsemide |
| Extended release torsemide 24mg tabletSubjects 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. | Drug | Extended release torsemide, Immediate release torsemide |
Primary outcome
Cumulative Na+ excretion over 6 hours
Time frame: 6 hours after lunch
The primary outcome is the cumulative Na+ excretion over 6 hours after lunch.
3 secondary outcomes
Fluid and Na+ excretion over the 6 hours
Time frame: 6 hours after breakfast, 6 hours after lunch, and 24 hours
creatinine clearance
Time frame: While in the study (approximately 2 weeks)
K+ excretion
Time frame: While in the study (approximately 2 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parta Hatamizadeh, MD, MPH principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immediate release torsemide 20mg tablet and Extended release torsemide 24mg tablet in people with Heart Failure, run by Sarfez Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Na+ excretion over 6 hours (time frame: 6 hours after lunch). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.