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Diuretic

Extended Release Torsemide for Overactive Bladder in Heart Failure

Phase 2
Recruiting
Led By Alvin Chandra, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 days

Summary

"This trial is comparing two types of the drug torsemide to see which one is better at reducing Overactive Bladder symptoms in patients with chronic heart failure. Patients will be monitored for eight weeks with

Who is the study for?
This trial is for people over 50 with chronic congestive heart failure (CHF) who are in NYHA functional class II-IV. They must be on a stable dose of furosemide and have an eGFR of ≥30 ml/min/1.73 m2, as well as symptoms of overactive bladder.
What is being tested?
The study compares extended release torsemide (ERT) to immediate release Torsemide (IRT) for reducing worsening symptoms of Overactive Bladder in CHF patients. It's an eight-week study with nine visits including physical exams, blood tests, and symptom diaries.
What are the potential side effects?
Possible side effects from torsemide include acute kidney injury, loss of fluids/electrolytes, allergic reactions, and reversible hearing issues like tinnitus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in average number of voiding, urgency, and urgency-incontinence episodes in the 2 groups

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational productExperimental Treatment2 Interventions
Extended release torsemide and immediate release torsemide placebo
Group II: Control productActive Control2 Interventions
Immediate release torsemide and extended release torsemide placebo

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Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,083 Previous Clinical Trials
1,058,165 Total Patients Enrolled
26 Trials studying Heart Failure
13,728 Patients Enrolled for Heart Failure
Sarfez Pharmaceuticals, Inc.Lead Sponsor
4 Previous Clinical Trials
98 Total Patients Enrolled
2 Trials studying Heart Failure
50 Patients Enrolled for Heart Failure
Alvin Chandra, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
~6 spots leftby Feb 2025
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