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

Launched by SARFEZ PHARMACEUTICALS, INC. · Jan 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two types of a medication called torsemide to see which one works better for patients with congestive heart failure (CHF) who also have overactive bladder (OAB). The study will compare an extended-release version of torsemide, which releases the medication slowly over time, to a regular version that releases the medication more quickly. The goal is to find out which version helps reduce OAB symptoms, like needing to urinate frequently or urgently, in patients who are already taking another diuretic medication for their heart condition.

To participate, you need to be at least 50 years old and have a diagnosis of CHF, along with symptoms of OAB. The study lasts about eight weeks and includes a total of nine visits, both in person and virtual. During these visits, you will answer questions about your symptoms and provide some health information. While participating, you may experience side effects from the medication, such as changes in kidney function or electrolyte levels, so it’s important to discuss any concerns with your doctor.

Gender

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Eligibility 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