A Crossover Study of Patients With HF to Compare Natriuretic Effects of IR Torsemide vs. ER Torsemide Over 12 Hrs
Withdrawn before enrolling · Phase 4
Conditions studied: Heart Failure
In brief
This is a randomized double-blind crossover study of the patients with stable heart failure, who are taking a loop diuretic. During the study period, the participants' loop diuretics will be replaced by the equivalent dose of immediate release/extended release torsemide for one week. After a one week period, they will report to the site and will receive a single dose of either immediate release or extended release Torsemide. The sodium excretion will be measured for six hours after dosing and for an additional six hours after a high salt lunch.
Key facts
- Study ID
- NCT06708611
- Run by
- Sarfez Pharmaceuticals, Inc.
- People needed
- 0
- Starts
- 2025-01-15
- Expected to finish
- 2025-03-25
- Last updated by the study team
- 2026-04-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 or an experienced clinician to be stable over the one-month period prior to randomization.
- Receiving oral furosemide (or equivalent doses of torsemide or bumetanide) for about 30 days prior to randomization.
- No anticipated changes in HF medications during the study period.
- Premenopausal women of child-bearing potential have a negative pregnancy test prior to beginning of the study and agree to use effective contraceptive methods during the study period
You may not qualify if…
- Requirement for a diuretic other than furosemide, bumetanide or torsemide except for spironolactone, eplerenone, finerenone, or SGLT2 inhibitors, at randomization and during the study.
- 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.
- Uncontrolled diabetes mellitus or uncontrolled hypertension.
- Estimated GFR < 30 ml/min/1.72m2.
- History of flash pulmonary edema or amyloid cardiomyopathy.
- Female patients who are breastfeeding.
Where it is running
- Future Life Clinical Trials — Miami, Florida, United States
Full record on ClinicalTrials.gov
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