← Back to Search

Diuretic

Investigational product for Overactive Bladder

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Difference in average number of voiding, urgency, and urgency-incontinence episodes in the 2 groups

Secondary outcome measures

To assess differences in the levels of NT-pro-BNP between the treatment arms and from the baseline

To assess differences in the six-minute walk test (6MWT) scores between the treatment arms and from the baseline.

To assess the change in score from the baseline in bladder symptoms (BS Tool).

+3 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,711 Total Patients Enrolled

Sarfez Pharmaceuticals, Inc.Lead Sponsor

4 Previous Clinical Trials

98 Total Patients Enrolled

Alvin Chandra, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals in total are participating in this research project?

"Indeed, as per the details on clinicaltrials.gov, this particular clinical trial is actively seeking participants. The initial posting of the trial was on March 1st, 2024, with the latest update made on March 11th, 2024. This study aims to recruit a total of 24 patients at one designated site."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"Yes, the information from clinicaltrials.gov confirms that this study is currently seeking participants. The trial was initially listed on March 1st, 2024 and last modified on March 11th, 2024. They aim to recruit a total of 24 patients at one site."

Answered by AI

What are the potential risks associated with the experimental medication for individuals involved in clinical trials?

"In this Phase 2 trial, the investigational product is rated at a safety level of 2 by our team. This indicates that while there is some evidence supporting its safety profile, no data currently supports its efficacy in clinical outcomes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Alvin Chandra 2024. "Effect of Extended Release Torsemide in Patients With Congestive Heart Failure and Overactive Bladder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06206512.

All > Overactive Bladder > Congestive Heart Failure