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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
Cardiometabolic Research Unit
RECRUITING
Dallas
Contact Information
Primary
Sophia Shah, MD
clinicaltrials@sarfez.com
877-872-7339
Backup
Chris Wilcox, MD, PhD
clinicaltrials@sarfez.com
877-872-7339
Time Frame
Start Date: 2024-06-15
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 24
Treatments
Experimental: Investigational product
Extended release torsemide and immediate release torsemide placebo
Active_comparator: Control product
Immediate release torsemide and extended release torsemide placebo
Related Therapeutic Areas
Sponsors
Leads: Sarfez Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov