Heart FailurePhase 4NEXT-HFNCT06995144
Comparing Natriuretic Effects of ER Torsemide to IR Torsemide in Patients With Heart Failure
A Phase 4 study testing Extended Release Torsemide Tablets and Immedate Release Torsemide Tablets in people with Heart Failure and Edema, run by Sarfez Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to learn whether a morning dose of extended-release torsemide enhances renal sodium excretion after lunch (4-8 hours after dosing) compared to immediate-release torsemide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Edema, Pulmonary Congestion
- What is being tested?
- Extended Release Torsemide Tablets and Immedate Release Torsemide Tablets
- 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
- May 2025to 16 Sep 2026
- 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
- Age: 18 years or older.
- Informed Consent: Willing and able to sign the informed consent form.
- Stable Chronic HF: A clinical diagnosis of chronic heart failure considered stable by the patient's cardiologist/physician or another experienced clinician for at least one month prior to randomization.
- Current Diuretic Therapy: Receiving an oral dose of 20 mg to 80 mg daily of furosemide, or 10 mg to 40 mg daily dose of torsemide, or 1 mg to 4 mg daily dose of bumetanide, for about 30 days prior to randomization.
- Stable HF Medications: No anticipated changes in HF medications during the study period.
- Female Participants: Premenopausal women of childbearing potential must have a negative pregnancy test prior to study initiation and agree to use effective contraceptive methods throughout the study period.
Who cannot join
- Other Diuretics: Requirement for a diuretic other than furosemide, bumetanide, or torsemide (except for spironolactone, eplerenone, finerenone, or SGLT2 inhibitors) at randomization or during the study.
- Recent Cardiovascular Events: Myocardial infarction, stroke, transient ischemic attack, acute kidney injury, or acute HF requiring hospitalization within 30 days prior to randomization.
- Severe Lung Disease: Severe or symptomatic lung disease or respiratory symptoms distinct from HF.
- Urinary Issues: History of urinary incontinence, or inability to empty the bladder.
- Uncontrolled Comorbidities: Uncontrolled diabetes mellitus or hypertension.
- Renal Dysfunction: Estimated GFR < 30 ml/min/1.72m².
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- Cardiac Conditions: History of flash pulmonary edema or amyloid cardiomyopathy.
- Breastfeeding: Female participants who are breastfeeding.
- Recent Participation in Clinical Trials: Participation in another clinical trial within the last three months prior to randomization.
- Requirements for treatment with a non-steroidal anti-inflammatory drug (except for Aspirin up to 200 mg as PRN daily).
- Serum potassium concentration <3.5 or >5.5 mmol/L.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Two-Period, Two-Arm, Double-Dummy, Crossover Study to Compare Natriuretic Effects of Extended Release Torsemide to Immediate Release Torsemide in Patients With Heart Failure (NEXT-HF)
The primary objective of this study is to learn whether a morning dose of extended-release torsemide enhances renal sodium excretion after lunch (4-8 hours after dosing) compared to immediate-release torsemide.
This is a randomized, double-blind, crossover study in patients with heart failure who are on a stable dose of a loop diuretic.
The primary endpoint will be urinary sodium excretion (4-8 hours after dosing). This will be compared between the extended-release arm and the immediate-release arm to assess the efficacy of prolonged diuretic action. In addition, urinary potassium and creatinine excretion and creatinine clearance will be measured in all urine samples as the safety endpoints.
Read the detailed description
Research Plan
Study Design
This is a double-blind, double-dummy, two-period, two-arm, randomized, crossover study.
Initial Study Procedures
Identification of Participants: Patients with a known history of stable heart failure (HF) for at least one month will be identified through healthcare records at clinical site, heart failure clinic, nephrology clinic, and other relevant clinics.
Treatment Arms and Crossover Design
- Arm 1: Approximately half of the participants will receive 20 mg IR torsemide followed by 24 mg ER torsemide or 40mg IR torsemide followed by 48 mg ER torsemide (6-10 days each).
- Arm 2: The other half will receive 24 mg ER torsemide followed by 20 mg IR torsemide, or 48 mg ER torsemide followed by 40 mg IR torsemide (6-10 days each).
- Dose Conversion:
- Patients on 20-40 mg furosemide will be converted to 20 mg IR torsemide or 24 mg ER torsemide.
- Patients on 60-80 mg furosemide will be converted to 40 mg torsemide (two 20 mg tablets) or 48 mg ER torsemide (two 24 mg tablets).
- Patients on 1 mg bumetanide will be converted to 20 mg IR torsemide or 24 mg ER torsemide, while those on 2 mg bumetanide will be converted to 40 mg torsemide or 48 mg ER torsemide.
- Double-Dummy Design: To maintain blinding, participants will also receive placebo corresponding to the medications in their arm, ensuring that participants and investigators remain unaware of their treatment assignment.
- Dietary Instructions: Participants will be instructed to follow a low-sodium diet with a daily intake of approximately 3 grams of sodium throughout the study period.
Test Day Procedures
The test day will occur on the last day of each treatment period, with participants staying at the site for 9-10 hours (no overnight stay). The study staff undertake the following:
- Medication Compliance: Collect study medications for pill count and assess compliance.
- Dosing:
- A standard breakfast will be served 30 minutes before dosing, and participants will be instructed to complete it within 30 minutes.
After completion of breakfast, participants will receive study medication along with 350 ml +/- 20 ml water.
- Post-dose Sample Collection:
- Urine samples will be collected at 0-4 hours and 4-8 hours after dosing. For each time point,total volume will be measured, and two 5 ml aliquots will be taken for sodium, potassium, and creatinine measurements. The remaining urine will be stored in a cool place for 48 hours or until laboratory results are sent to the site and reviewed by the PI for any discrepancy.
- After 4 hours post-breakfast, a lunch containing salt will be served, and participants will complete it within 30 minutes.
- Participants will be instructed to collect urine for the following 16 hours at home to complete the 24-hour collection, with the urine sample returned to the site for recording of volume and processing.
- Participants will not be permitted to eat except of the site provide breakfast and lunch, and they will be asked consume all the food (breakfast and lunch; no additional snacks or other food items).
- Participants will be allowed to consume water, but no flavored drinks or sodas, as they require.
- Participants will be reminded to empty their bladder completely during the each time point. Bladder emptying time (i.e., passing urine) and urine volume will be recorded.
- After completion of the 4-8 hours urine collection, participants will be given a urine collection container and will be instructed to collect all the urine passed into the container until 24 hours after the dosing time (site will provide dosing time to the participants).
- The container will be collected next morning by the site personnel, who will bring the container to site. Upon receiving the container, site staff will measure the volume, take two 5 ml aliquots for sample analysis.
Sample Collection Timepoints
- Urine Samples:
- Post-dose Visit 3 (Test Day of Period 1):Collect urine samples at 0-4 hours, 4-8 hours After Test Day of Period 1: 8-24 hours (measure and record total volume for each).
Visit 4 (test day of Period 2): Collect urine samples at 0-4 hours, 4-8 hours. After Test Day of Period 2: 8-24 hours (measure and record total volume for each).
- Blood Samples:
- Visit 1 (screening): Collect 10-12 ml venous blood for CMP-14 with eGFR testing.
- Visit 3 (Test Day of Period 1): Collect 10-12 ml venous blood for CMP-14 with eGFR.
- Visit 4 (test day of Period 2): Collect 10-12 ml venous blood for CMP-14 with eGFR.
Analytes/Measurements
- Blood Samples:
- Screening: CMP-14 with eGFR
- Test day of period 1: CMP-14 with eGFR
- Test day of period 2: CMP-14 with eGFR
- Urine Samples:
- Test Day (Post-dose 0-4, 4-8, and 8-24 hours): Urine volume, sodium, potassium, and creatinine.
End of Study Procedures
At the end of the study period, participants will:
- Resume their pre-enrollment diuretic regimen.
- Continue routine follow-up with their physicians for standard care.
- Conditions
- Heart Failure, Edema, Pulmonary Congestion, Fluid Overload
- Being tested
- Extended Release Torsemide Tablets, Immedate Release Torsemide Tablets
- Keywords
- heart failure, natriuretic, torsemide, Soaanz, extended release, diuretic, sodium retention, water retention, renal clearance, low-sodium, diet, prolonged diuretic action, loop diuretic, urinary sodium excretion, furosemide, bumetanide, chronic kidney disease
- Medical subject headings
- Heart Failure, Edema, Hypernatremia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Release Torsemide TabletsDrug
Also called ER Torsemide tablets
Extended release torsemide vs Immediate release torsemide
Immedate Release Torsemide TabletsDrug
Also called IR Torsemide Tablets
Immediate release torsemide vs Extended release torsemide
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 IR torsemide | Active comparator | Approximately half of the participants will receive 20 mg IR torsemide followed by 24 mg ER torsemide or 40mg IR torsemide followed by 48 mg ER torsemide (6-10 days each) Receives: Drug: Extended Release Torsemide Tablets; Drug: Immedate Release Torsemide Tablets |
| ARM 2 ER torsemide | Active comparator | The other half will receive 24 mg ER torsemide followed by 20 mg IR torsemide, or 48 mg ER torsemide followed by 40 mg IR torsemide (6-10 days each) Receives: Drug: Extended Release Torsemide Tablets; Drug: Immedate Release Torsemide Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary sodium excretion measurement
Urinary sodium excretion (mmol) measured after dosing: 4-8 hours (post-lunch period)
Measured: 4-8 hours (post-lunch period)
Secondary outcomes (1)
Urinary sodium excretion
The secondary endpoints are urinary sodium excretion (mmol) after dosing:
- 0-4 hours (pre-lunch period)
- 8-24 hours (post-lunch period)
- Safety endpoints include:
- Creatinine clearance (mmol, 0-4, 4-8, and 8-24 hours after dosing)
- Urinary potassium excretion (mmol, 0-4, 4-8, and 8-24 hours after dosing)
Measured: 0-4 hours (pre-lunch period) and 8-24 hours (post-lunch period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study startMay 2025 (estimated)
- Primary completion16 Sep 2026
- Study completion16 Sep 2026
Why it stopped: No participants enrolled
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
- Randomized, Two-Period, Two-Arm, Double-Dummy, Crossover Study to Compare Natriuretic Effects of Extended Release Torsemide to Immediate Release Torsemide in Patients with Heart Failure (NEXT-HF)
- 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
- Salim Shah, PhD, JD, Study chair, Sarfez Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995144
- Sponsor's protocol ID
- SAR-2025-019
- Acronym
- NEXT-HF
- Status last verified
- Sep 2026
- First submitted
- 16 May 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: HIPAA
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Two-Period, Two-Arm, Double-Dummy, Crossover Study to Compare Natriuretic Effects of Extended Release Torsemide to Immediate Release Torsemide in Patients With Heart Failure (NEXT-HF)
- ClinicalTrials.gov ID
- NCT06995144
- Acronym / sponsor ID
- NEXT-HF / SAR-2025-019
- Conditions
- Heart Failure, Edema, Pulmonary Congestion, Fluid Overload
- Keywords
- heart failure, natriuretic, torsemide, Soaanz, extended release, diuretic, sodium retention, water retention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sarfez Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- 16 Sep 2026 (actual)
- Study completion
- 16 Sep 2026 (actual)
- First posted
- 29 May 2025 (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 primary objective of this study is to learn whether a morning dose of extended-release torsemide enhances renal sodium excretion after lunch (4-8 hours after dosing) compared to immediate-release torsemide.
This is a randomized, double-blind, crossover study in patients with heart failure who are on a stable dose of a loop diuretic.
The primary endpoint will be urinary sodium excretion (4-8 hours after dosing). This will be compared between the extended-release arm and the immediate-release arm to assess the efficacy of prolonged diuretic action. In addition, urinary potassium and creatinine excretion and creatinine clearance will be measured in all urine samples as the safety endpoints.
Detailed description
Research Plan
Study Design
This is a double-blind, double-dummy, two-period, two-arm, randomized, crossover study.
Initial Study Procedures
Identification of Participants: Patients with a known history of stable heart failure (HF) for at least one month will be identified through healthcare records at clinical site, heart failure clinic, nephrology clinic, and other relevant clinics.
Treatment Arms and Crossover Design
- Arm 1: Approximately half of the participants will receive 20 mg IR torsemide followed by 24 mg ER torsemide or 40mg IR torsemide followed by 48 mg ER torsemide (6-10 days each).
- Arm 2: The other half will receive 24 mg ER torsemide followed by 20 mg IR torsemide, or 48 mg ER torsemide followed by 40 mg IR torsemide (6-10 days each).
- Dose Conversion:
- Patients on 20-40 mg furosemide will be converted to 20 mg IR torsemide or 24 mg ER torsemide.
- Patients on 60-80 mg furosemide will be converted to 40 mg torsemide (two 20 mg tablets) or 48 mg ER torsemide (two 24 mg tablets).
- Patients on 1 mg bumetanide will be converted to 20 mg IR torsemide or 24 mg ER torsemide, while those on 2 mg bumetanide will be converted to 40 mg torsemide or 48 mg ER torsemide.
- Double-Dummy Design: To maintain blinding, participants will also receive placebo corresponding to the medications in their arm, ensuring that participants and investigators remain unaware of their treatment assignment.
- Dietary Instructions: Participants will be instructed to follow a low-sodium diet with a daily intake of approximately 3 grams of sodium throughout the study period.
Test Day Procedures
The test day will occur on the last day of each treatment period, with participants staying at the site for 9-10 hours (no overnight stay). The study staff undertake the following:
- Medication Compliance: Collect study medications for pill count and assess compliance.
- Dosing:
- A standard breakfast will be served 30 minutes before dosing, and participants will be instructed to complete it within 30 minutes.
After completion of breakfast, participants will receive study medication along with 350 ml +/- 20 ml water.
- Post-dose Sample Collection:
- Urine samples will be collected at 0-4 hours and 4-8 hours after dosing. For each time point,total volume will be measured, and two 5 ml aliquots will be taken for sodium, potassium, and creatinine measurements. The remaining urine will be stored in a cool place for 48 hours or until laboratory results are sent to the site and reviewed by the PI for any discrepancy.
- After 4 hours post-breakfast, a lunch containing salt will be served, and participants will complete it within 30 minutes.
- Participants will be instructed to collect urine for the following 16 hours at home to complete the 24-hour collection, with the urine sample returned to the site for recording of volume and processing.
- Participants will not be permitted to eat except of the site provide breakfast and lunch, and they will be asked consume all the food (breakfast and lunch; no additional snacks or other food items).
- Participants will be allowed to consume water, but no flavored drinks or sodas, as they require.
- Participants will be reminded to empty their bladder completely during the each time point. Bladder emptying time (i.e., passing urine) and urine volume will be recorded.
- After completion of the 4-8 hours urine collection, participants will be given a urine collection container and will be instructed to collect all the urine passed into the container until 24 hours after the dosing time (site will provide dosing time to the participants).
- The container will be collected next morning by the site personnel, who will bring the container to site. Upon receiving the container, site staff will measure the volume, take two 5 ml aliquots for sample analysis.
Sample Collection Timepoints
- Urine Samples:
- Post-dose Visit 3 (Test Day of Period 1):Collect urine samples at 0-4 hours, 4-8 hours After Test Day of Period 1: 8-24 hours (measure and record total volume for each).
Visit 4 (test day of Period 2): Collect urine samples at 0-4 hours, 4-8 hours. After Test Day of Period 2: 8-24 hours (measure and record total volume for each).
- Blood Samples:
- Visit 1 (screening): Collect 10-12 ml venous blood for CMP-14 with eGFR testing.
- Visit 3 (Test Day of Period 1): Collect 10-12 ml venous blood for CMP-14 with eGFR.
- Visit 4 (test day of Period 2): Collect 10-12 ml venous blood for CMP-14 with eGFR.
Analytes/Measurements
- Blood Samples:
- Screening: CMP-14 with eGFR
- Test day of period 1: CMP-14 with eGFR
- Test day of period 2: CMP-14 with eGFR
- Urine Samples:
- Test Day (Post-dose 0-4, 4-8, and 8-24 hours): Urine volume, sodium, potassium, and creatinine.
End of Study Procedures
At the end of the study period, participants will:
- Resume their pre-enrollment diuretic regimen.
- Continue routine follow-up with their physicians for standard care.
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
- Randomized, Two-Period, Two-Arm, Double-Dummy, Crossover Study to Compare Natriuretic Effects of Extended Release Torsemide to Immediate Release Torsemide in Patients with Heart Failure (NEXT-HF)
| Arm | Type | Receives |
|---|---|---|
| Arm 1 IR torsemide | Active comparator | Drug: Extended Release Torsemide Tablets, Drug: Immedate Release Torsemide TabletsApproximately half of the participants will receive 20 mg IR torsemide followed by 24 mg ER torsemide or 40mg IR torsemide followed by 48 mg ER torsemide (6-10 days each) |
| ARM 2 ER torsemide | Active comparator | Drug: Extended Release Torsemide Tablets, Drug: Immedate Release Torsemide TabletsThe other half will receive 24 mg ER torsemide followed by 20 mg IR torsemide, or 48 mg ER torsemide followed by 40 mg IR torsemide (6-10 days each) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18 years or older.
- Informed Consent: Willing and able to sign the informed consent form.
- Stable Chronic HF: A clinical diagnosis of chronic heart failure considered stable by the patient's cardiologist/physician or another experienced clinician for at least one month prior to randomization.
- Current Diuretic Therapy: Receiving an oral dose of 20 mg to 80 mg daily of furosemide, or 10 mg to 40 mg daily dose of torsemide, or 1 mg to 4 mg daily dose of bumetanide, for about 30 days prior to randomization.
- Stable HF Medications: No anticipated changes in HF medications during the study period.
Key exclusion criteria (11 listed)
- Other Diuretics: Requirement for a diuretic other than furosemide, bumetanide, or torsemide (except for spironolactone, eplerenone, finerenone, or SGLT2 inhibitors) at randomization or during the study.
- Recent Cardiovascular Events: Myocardial infarction, stroke, transient ischemic attack, acute kidney injury, or acute HF requiring hospitalization within 30 days prior to randomization.
- Severe Lung Disease: Severe or symptomatic lung disease or respiratory symptoms distinct from HF.
- Urinary Issues: History of urinary incontinence, or inability to empty the bladder.
- Uncontrolled Comorbidities: Uncontrolled diabetes mellitus or 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 |
|---|---|---|
| Extended Release Torsemide TabletsAlso: ER Torsemide tabletsExtended release torsemide vs Immediate release torsemide | Drug | ARM 2 ER torsemide, Arm 1 IR torsemide |
| Immedate Release Torsemide TabletsAlso: IR Torsemide TabletsImmediate release torsemide vs Extended release torsemide | Drug | ARM 2 ER torsemide, Arm 1 IR torsemide |
Primary outcome
Urinary sodium excretion measurement
Time frame: 4-8 hours (post-lunch period)
Urinary sodium excretion (mmol) measured after dosing: 4-8 hours (post-lunch period)
1 secondary outcome
Urinary sodium excretion
Time frame: 0-4 hours (pre-lunch period) and 8-24 hours (post-lunch period)
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 28 Sep 2026.
- Individual participant dataSharing planned: Undecided. HIPAA
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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.
Salim Shah, PhD, JD study chair
Sarfez Pharmaceuticals, Inc.
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 Extended Release Torsemide Tablets and Immedate Release Torsemide Tablets in people with Heart Failure and Edema, 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 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 28 Sep 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?
Urinary sodium excretion measurement (time frame: 4-8 hours (post-lunch period)). 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 28 Sep 2026.