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

NCT06206512 | Completed Phase 2 FDA Drug

• 1 other identifier: SAR065-124
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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

Heart Failure; Overactive Bladder; Incontinence

Outcome Measures

Primary Outcomes (1)

• Health-Related Quality of Life (HRQoL) Treatment Effect

  Within-subject difference in change from baseline in HRQoL total score between extended-release torsemide (ERT) and immediate-release torsemide (IRT) treatment periods. Clinical significance interpreted using a Patient Global Impression of Change (PGI-C)-anchored minimum clinically important difference (MCID).

  After enrollment to the end of treatment at 8 weeks

Secondary Outcomes (7)

• Voiding, Urgency, and Urgency-Incontinence Episodes (24-hour)

  After enrollment to the end of treatment at 8 weeks

• Voiding, Urgency, and Urgency-Incontinence Episodes (8-hour)

  After enrollment to the end of treatment at 8 weeks

• Bladder Symptom Assessment (BSA) Score

  After enrollment to the end of treatment at 8 weeks

• Health-Related Quality of Life (HRQoL) Responder Proportion

  After enrollment to the end of treatment at 8 weeks

• Patient Global Impression of Change (PGI-C)

  After enrollment to the end of treatment at 8 weeks

Study Arms (2)

Investigational product

EXPERIMENTAL

Extended release torsemide and immediate release torsemide placebo

Drug: Extended release torsemide; Drug: Immediate release torsemide placebo

Control product

ACTIVE COMPARATOR

Immediate release torsemide and extended release torsemide placebo

Drug: Immediate release torsemide; Drug: Extended release torsemide placebo

Interventions

Extended release torsemide DRUG

This is an extended-release formulation of torsemide

Investigational product

Immediate release torsemide DRUG

This is the generic, immediate release formulation of torsemide

Control product

Extended release torsemide placebo DRUG

Placebo of extended release torsemide

Control product

Immediate release torsemide placebo DRUG

Placebo of immediate release torsemide

Investigational product

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients with an estimated glomerular filtration rate (eGFR) of ≥30 ml/min/1.73 m2.
• Patients with symptoms of overactive bladder.

You may not qualify if:

• The patients with an estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73 m2
• 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

Sponsors & Collaborators

• Sarfez Pharmaceuticals, Inc.: lead

Study Sites (1)

Cardiometabolic Research Unit

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Heart Failure; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alvin Chandra, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover, double blinded, two-period, two-treatment, two-sequence, double dummy

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: June 15, 2024
• Primary Completion: November 17, 2025
• Study Completion: March 9, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)