Effect of Extended Release Torsemide in Patients With Congestive Heart Failure and Overactive Bladder

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Failure, Overactive Bladder, Incontinence

In brief

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.

Key facts

Study ID

NCT06206512

Run by

Sarfez Pharmaceuticals, Inc.

People needed

24

Starts

2024-06-15

Expected to finish

2026-03-09

Last updated by the study team

2026-03-12

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• The patients with an estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73 m2
• Any known allergy to diuretics or sulphonamide-derived compounds
• Serum potassium concentration (K+) equal to or below 3.5 mEq/ L (mmol/L).
• History of myocardial infarction or stroke within the preceding 3 months duration
• Inability to comprehend or comply with the informed consent (including a physician's assessment of prior drug non-compliance).
• Urinalysis containing white blood cells indicative of urinary tract infection
• Patients with liver cirrhosis
• 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

Where it is running

• Cardiometabolic Research Unit — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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