NCT06206512CompletedPhase 2
Effect of Extended Release Torsemide in Patients With Congestive Heart Failure and Overactive Bladder
A Crossover, Double-blinded, Two-period, Double Dummy Study to Evaluate the Effects of Extended Release Torsemide in Patients With Chronic Congestive Heart Failure and Symptoms of Overactive Bladder
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
This research study is being done to compare the effectiveness two drugs: an Extended Release Torsemide (ERT) versus generic Immediate Release Torsemide (IRT) in reducing the worsening of symptoms of Overactive Bladder (OAB, i.e., frequency, urgency, or urgency incontinence) in patients with chronic congestive heart failure (CHF). This study will include CHF patients who experience worsening (OAB) symptoms with use of a loop diuretic. The total duration of the study is about eight weeks with a total of nine visits. There will be a screening visit that lasts one to two hours. The screening visit includes history and physical exams, blood draws, and urine analysis. If eligible for the study, participants will receive either generic torsemide or extended release torsemide for the first four weeks. Participants will do a virtual research visit on week one, two and three to submit a symptom diary and answer a questionnaire about urinary symptoms. At four weeks, history and physician exam will be done and blood will be collected. Participants will be assigned to receive either extended release torsemide (if they initially received generic torsemide) and generic torsemide (if they initially received extended release torsemide) for the next four weeks. Participants will attend virtual research visits on week five, six and seven to submit a symptom diary and answer a questionnaire about urinary symptoms. At the end of the study in week eight, they will have history and physical exams and blood draws. Some risks from the study may include side effects of torsemide like acute kidney injury, fluid/electrolyte loss, hypersensitivity reactions and reversible hearing loss/tinnitus.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 4 Jan 2024
- Start date
- 15 Jun 2024
- Primary completion date
- 17 Nov 2025
- Lead sponsor
- Sarfez Pharmaceuticals, Inc.
- Diseases
- Heart failure
- NCT number
- NCT06206512
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 24
- From 15 Jun 2024 to the primary completion date, 17 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to comprehend or comply with the informed consent (including a physician's assessment of prior drug non-compliance).
- Any bladder catheterization, bladder, or prostrate surgery and/or, bladder, prostate, or pelvic radiotherapy within the last 3 months duration
- Patients who have participated in another clinical study in the past 3 months prior to commencement of this study
Other illness
- Any known allergy to diuretics or sulphonamide-derived compounds
- History of myocardial infarction or stroke within the preceding 3 months duration
Lab values
- The patients with an estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73 m2
- Serum potassium concentration (K+) equal to or below 3.5 mEq/ L (mmol/L).
- Urinalysis containing white blood cells indicative of urinary tract infection
Other
- Patients with liver cirrhosis
Who the study is looking for
- Patients of either gender of ≥50 years with clinical diagnosis of CHF.
- Patients with NYHA (New York Heart Association) functional class of II-IV.
- Patients receiving stable dose of furosemide 40mg or 80mg.
- Patients with an estimated glomerular filtration rate (eGFR) of ≥30 ml/min/1.73 m2.
- Patients with symptoms of overactive bladder.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiometabolic Research Unit Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.