A Crossover Study of Patients with HF to Compare Natriuretic Effects of IR Torsemide Vs. ER Torsemide Over 12 Hrs (EXTOR-HF)

Sarfez Pharmaceuticals

Status and phase: Terminated; Phase 4

Conditions: Heart Failure

Treatments: Drug: torsemide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06708611

SAR065-324

Details and patient eligibility

About

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.

Full description

The goal of this randomized double-blind crossover study is to assess whether extended release torsemide has a better efficacy than immediate release torsemide to induce renal sodium excretion after a salty lunch in patients with heart failure. The study will address if:

• the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a morning dose of extended release torsemide is different from the amounts after the immediate release torsemide.
• the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, is different from the amounts after the immediate release torsemide.
• the amount of excreted sodium in the urine during the 24 hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, is different from the amount after the immediate release torsemide.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups

Extended release torsemide

Experimental group

Description:

Drug: Extended release torsemide 24 mg tablet. Subjects will receive oral dose of 24 mg extended release torsemide tablet and a placebo of 20 mg immediate release torsemide.

Treatment:

Drug: torsemide

Immediate release torsemide

Active Comparator group

Description:

Drug: Immediate release torsemide 20 mg tablet. Subjects will receive oral dose of 20 mg of immediate release torsemide and a placebo of 24 mg extended release torsemide.

Treatment:

Drug: torsemide