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WithdrawnNCT06708611EXTOR-HFUpdated Apr 27, 2026

A Crossover Study of Patients With HF to Compare Natriuretic Effects of IR Torsemide vs. ER Torsemide Over 12 Hrs

A Phase 4 interventional study of torsemide 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 Withdrawn at 1 site in United States.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 4, Interventional, and Treatment

Why this study was withdrawn
Recruitment issues
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

Browse Heart Failure studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Man or woman over the age of 18 years.
  • Willing and able to sign the .
  • 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 have a negative pregnancy test prior to beginning of the study and agree to use effective methods during the study period

Exclusion criteria

Exclusion Criteria:

  • 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, , 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 \< 30 ml/min/1.72m2.
  • History of flash pulmonary edema or amyloid cardiomyopathy.
  • Female patients who are breastfeeding.
Terms in these criteria, in plain language(5)

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.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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.

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Extended release torsemide

    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.

    Drug: torsemide

  • Active comparator
    Immediate release torsemide

    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.

    Drug: torsemide

Interventions

  • Extended release formulation of torsemide

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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]

  2. Creatinine clearance

    Safety outcome

    Time frame: While in the study (approximately 2 weeks)

  3. K+ excretion

    Safety outcome

    Time frame: While in the study (approximately 2 weeks)

07

Study locations

1 site
  • Future Life Clinical Trials
    Miami, Florida 33169, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06708611
Lead sponsor
Sarfez Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Nov 27, 2024
Start date
Jan 15, 2025
Primary completion
Mar 25, 2025
Completion
Mar 25, 2025
Last update
Apr 27, 2026

Study contacts

Sophia Shah, MD
study director · Safez Pharmaceuticals
Nayle A Ancares, MD
principal investigator · Future Life Clinical Trials

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Studies of the drug tested here: Torsemide

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