Effect of Extended Release Torsemide in Patients With Congestive Heart Failure and Overactive Bla… (NCT06206512) | Clinical Trial Compass
CompletedPhase 2
Effect of Extended Release Torsemide in Patients With Congestive Heart Failure and Overactive Bladder
United States24 participantsStarted 2024-06-15
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested extended-release torsemide specifically for people who have both heart failure and overactive bladder or incontinence — does that match my situation closely enough that the findings would be relevant to my care?
2Since this was a Phase 2 trial and it's now completed, what do the results suggest about whether extended-release torsemide actually improved quality of life for people dealing with both fluid overload and bladder urgency, and how confident can we be in those findings?
3I currently take a diuretic for my heart failure — would switching to or trying extended-release torsemide make sense for me, or is my current treatment already doing a good enough job managing both my heart and bladder symptoms?
4Phase 2 trials are typically focused on early safety and how well a treatment works in a smaller group — are there any side effects or risks from this extended-release formulation that showed up in the trial that I should know about before we discuss it as an option?
5If the quality-of-life results from this trial look promising, is there a next step — like a larger Phase 3 trial or an approved use — that might make this treatment more accessible to me in the near future?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Health-Related Quality of Life (HRQoL) Treatment Effect
Timeframe: After enrollment to the end of treatment at 8 weeks