Status:
RECRUITING
Effect of Extended Release Torsemide in Patients With Congestive Heart Failure and Overactive Bladder
Lead Sponsor:
Sarfez Pharmaceuticals, Inc.
Conditions:
Heart Failure
Overactive Bladder
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
This study has been designed to evaluate the efficacy of 24mg/48mg once daily dose of Investigational Product \[Extended release torsemide of Sarfez Pharmaceuticals Inc.\] to 20mg/40mg once daily dose...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06206512
Start Date
June 15 2024
End Date
July 30 2026
Last Update
January 8 2026
Active Locations (1)
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1
Cardiometabolic Research Unit
Dallas, Texas, United States, 75390