Status:
TERMINATED
Immediate Release Torsemide Versus Extended Release Torsemide After Salty Meal
Lead Sponsor:
Sarfez Pharmaceuticals, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this randomized double-blind crossover study is to assess whether a morning dose of the extended release torsemide has a better efficacy than the ordinary immediate release torsemide to in...
Detailed Description
Sarfez Inc has developed an extended release formulation of torsemide, whose effect lasts for several hours after the dosing. The purpose of this study is to assess whether a morning dose of the exten...
Eligibility Criteria
Inclusion
- Man or woman over the age of 18 years.
- Willing and able to sign the informed consent.
- A clinical diagnosis of chronic HF that is considered by patient's cardiologist/physician to be stable over the one-month period prior to randomization.
- Receiving a stable dose of furosemide of 40mg or 80mg total per day (or equivalent doses of torsemide or bumetanide) for at least 30 days prior to randomization.
- Optimum volume status determined by experienced physician.
- Able to consume a diet containing approximately 3 grams of Na+ daily.
- No anticipated changes in HF medications during the study period.
Exclusion
- Requirement for a diuretic other than furosemide, bumetanide or torsemide except for spironolactone, eplerenone, finerenone, or SGLT2 inhibitors, given in stable dose for \> 2 weeks before randomization and during the study.
- Known non-adherence to medication intake or salt restriction.
- Myocardial infarction, stroke, transient ischemic attack, acute kidney injury or acute HF requiring admission to hospital within the last 30 days prior to randomization.
- Severe / symptomatic lung disease or respiratory symptoms distinct from HF.
- Urinary incontinence or inability to empty bladder with a post-void residual volume \>100 ml.
- Uncontrolled diabetes mellitus or uncontrolled hypertension.
- Estimated GFR \< 30 ml/min/1.72m2 of body surface area.
- Use of any non-loop diuretic in the last 30 days prior to randomization, with the exception of a low dose MRA (e.g., spironolactone of 25-50 mg per day) or an SGLT2 inhibitor.
- History of flash pulmonary edema or amyloid cardiomyopathy.
- Requirement for a non-steroidal anti-inflammatory drug other than low dose aspirin (\<200 mg daily)
- Refusal or inability to sign the informed consent.
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2025
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT06176794
Start Date
November 15 2024
End Date
March 25 2025
Last Update
March 26 2025
Active Locations (1)
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1
Division of Nephrology, Hypertension & Renal Transplantation, University of Florida
Gainesville, Florida, United States, 32610