MedTrace Logo

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

NCT06206512 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Extended release torsemide

This is an extended-release formulation of torsemide

DRUG

Immediate release torsemide

This is the generic, immediate release formulation of torsemide

DRUG

Extended release torsemide placebo

Placebo of extended release torsemide

DRUG

Immediate release torsemide placebo

Placebo of immediate release torsemide

Sponsors & Collaborators

  • Sarfez Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Alvin Chandra, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2025-11-17
Completion
2026-03-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06206512 on ClinicalTrials.gov