CompletedPhase 4

Comparing Natriuretic Effects of ER Torsemide to IR Torsemide in Patients With Heart Failure

United States20 participantsStarted 2025-05-28

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 mellit…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared an extended-release (ER) version of torsemide to the regular immediate-release (IR) version — since the trial is already completed, has my doctor seen any results about which form caused more sodium to be excreted in the urine, and would that affect which version might be right for me?
2Since this is a Phase 4 trial — meaning torsemide itself is already an approved medication — does my doctor think there's enough known about the safety of both the ER and IR forms for me to consider either one as part of my current heart failure treatment?
3My main symptoms include fluid overload and edema — based on what this trial was studying about sodium excretion, how would my doctor explain whether getting more sodium out through urine would actually translate to meaningful relief of my swelling and congestion?
4This trial is now completed, so are the full results published or available anywhere my doctor could review before we decide whether ER torsemide might be a better fit for me than the standard IR version I may already be taking or considering?
5Given that I have heart failure and this trial was specifically measuring how well these diuretics flush out sodium, are there other factors in my health history — like kidney function or blood pressure — that would make my doctor lean toward one formulation over the other regardless of what this trial found?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Urinary sodium excretion measurement

Timeframe: 4-8 hours (post-lunch period)

Trial details

NCT IDNCT06995144

SponsorSarfez Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-30

View on ClinicalTrials.gov More Heart Failure trials