Comparing two forms of torsemide for heart failure patients with 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
This study tests if a new form of torsemide that works longer can help heart failure patients with overactive bladder feel less urgency and go to the bathroom less often compared to the regular version.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Sarfez Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06206512 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of extended release torsemide compared to immediate release torsemide in patients with chronic congestive heart failure who also experience symptoms of overactive bladder. Participants will receive either medication for four weeks, with regular virtual check-ins to monitor symptoms and collect data. The study aims to determine if the extended release formulation can reduce urinary urgency and frequency more effectively than the immediate release version. The total duration of the study is approximately eight weeks, including a screening visit and follow-up assessments.
Who should consider this trial
Good fit: Ideal candidates are patients aged 50 and older with chronic heart failure and symptoms of overactive bladder who are on a stable dose of loop diuretics.
Not a fit: Patients with an estimated glomerular filtration rate below 30 ml/min/1.73 m2 or those with certain contraindications to diuretics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for heart failure patients suffering from overactive bladder symptoms.
How similar studies have performed: Previous studies have shown that extended release torsemide can effectively reduce peak urine volume, indicating potential success for this approach in a similar patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 daily for (\>30 days). * Patients with an estimated glomerular filtration rate (eGFR) of ≥30 ml/min/1.73 m2 * Patients with symptoms of overactive bladder Exclusion Criteria: * The patients with an estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73 m2 * Requirement for a non-steroidal anti-inflammatory drug (NSAID), cyclooxygenase-2 (Cox-2) inhibitor (e.g., Celecoxib) or Allopurinol. If the patients are receiving these agents, they may be switched to acetaminophen, if agreed by the investigator and the dosing to be maintained throughout the study. * 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 this trial is running
Dallas, Texas
- Cardiometabolic Research Unit — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Alvin Chandra, MD — University of Texas Southwestern Medical Center
- Study coordinator: Sophia Shah, MD
- Email: clinicaltrials@sarfez.com
- Phone: 877-872-7339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.