A Crossover Study of Patients With HF to Compare Natriuretic Effects of IR Torsemide vs. ER Torsemide Over 12 Hrs

Trial details

Who runs it

Sarfez Pharmaceuticals, Inc.

Trial code

NCT06708611

Record updated

27 April 2026

Original description

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.Read full original descriptionShow less

A Crossover Study to Compare Natriuretic Effects of Extended Release Torsemide to Immediate Release Torsemide Over 12 Hours After Dosing in Patients With Heart Failure (EXTOR-HF)

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.

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 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.

Exclusion: 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; Uncontrolled diabetes mellitus or uncontrolled hypertension; History of flash pulmonary edema or amyloid cardiomyopathy; Estimated GFR < 30 ml/min/1.72m2; Urinary incontinence or inability to empty bladder; Female patients who are breastfeeding.

ClinicalTrials.gov NCT06708611