Heart FailurePhase 4EXTOR-HFNCT06708611
A Crossover Study of Patients With HF to Compare Natriuretic Effects of IR Torsemide vs. ER Torsemide Over 12 Hrs
A Phase 4 study testing torsemide in people with Heart Failure, run by Sarfez Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. 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?
- torsemide
- 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 Jan 2025to 25 Mar 2025
- Phase
- Phase 4
- 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 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read the 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
- Being tested
- torsemide
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
torsemideDrug
Extended release formulation of torsemide
| Study group | Role | What they receive |
|---|---|---|
| Extended release torsemide | Experimental | 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. Receives: Drug: torsemide |
| Immediate release torsemide | Active comparator | 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. Receives: Drug: torsemide |
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 posted27 Nov 2024
- Study start15 Jan 2025
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, double-dummy, two-period, two arm, randomized, crossover clinical trial.
- 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
- Sophia Shah, MD, Study director, Safez PharmaceuticalsNayle A Ancares, MD, Principal investigator, Future Life Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708611
- Sponsor's protocol ID
- SAR065-324
- Acronym
- EXTOR-HF
- Status last verified
- Apr 2026
- First submitted
- 24 Nov 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 to Compare Natriuretic Effects of Extended Release Torsemide to Immediate Release Torsemide Over 12 Hours After Dosing in Patients With Heart Failure (EXTOR-HF)
- ClinicalTrials.gov ID
- NCT06708611
- Acronym / sponsor ID
- EXTOR-HF / SAR065-324
- Conditions
- Heart Failure
- Phase
- Phase 4
- 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 Jan 2025 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 27 Nov 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, double-dummy, two-period, two arm, randomized, crossover clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Extended release torsemide | Experimental | Drug: torsemideDrug: 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 | Active comparator | Drug: torsemideDrug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| torsemideExtended release formulation of torsemide | 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.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Sophia Shah, MD study director
Safez Pharmaceuticals
Nayle A Ancares, MD principal investigator
Future Life Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing torsemide 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 6 inclusion and 8 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.