Comparing Natriuretic Effects of ER Torsemide to IR Torsemide in Patients With Heart Failure

Completed · Phase 4

Conditions studied: Heart Failure, Edema, Pulmonary Congestion, Fluid Overload

In brief

The primary objective of this study is to learn whether a morning dose of extended-release torsemide enhances renal sodium excretion after lunch (4-8 hours after dosing) compared to immediate-release torsemide. This is a randomized, double-blind, crossover study in patients with heart failure who are on a stable dose of a loop diuretic. The primary endpoint will be urinary sodium excretion (4-8 hours after dosing). This will be compared between the extended-release arm and the immediate-release arm to assess the efficacy of prolonged diuretic action. In addition, urinary potassium and creatinine excretion and creatinine clearance will be measured in all urine samples as the safety endpoints.

Key facts

Study ID

NCT06995144

Run by

Sarfez Pharmaceuticals, Inc.

People needed

20

Starts

2025-05-28

Expected to finish

2025-12-30

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18 years or older.
• Informed Consent: Willing and able to sign the informed consent form.
• Stable Chronic HF: A clinical diagnosis of chronic heart failure considered stable by the patient's cardiologist/physician or another experienced clinician for at least one month prior to randomization.
• Current Diuretic Therapy: Receiving an oral dose of 20 mg to 80 mg daily of furosemide, or 10 mg to 40 mg daily dose of torsemide, or 1 mg to 4 mg daily dose of bumetanide, for about 30 days prior to randomization.
• Stable HF Medications: No anticipated changes in HF medications during the study period.
• Female Participants: Premenopausal women of childbearing potential must have a negative pregnancy test prior to study initiation and agree to use effective contraceptive methods throughout the study period.

You may not qualify if…

• Other Diuretics: Requirement for a diuretic other than furosemide, bumetanide, or torsemide (except for spironolactone, eplerenone, finerenone, or SGLT2 inhibitors) at randomization or during the study.
• Recent Cardiovascular Events: Myocardial infarction, stroke, transient ischemic attack, acute kidney injury, or acute HF requiring hospitalization within 30 days prior to randomization.
• Severe Lung Disease: Severe or symptomatic lung disease or respiratory symptoms distinct from HF.
• Urinary Issues: History of urinary incontinence, or inability to empty the bladder.
• Uncontrolled Comorbidities: Uncontrolled diabetes mellitus or hypertension.
• Renal Dysfunction: Estimated GFR < 30 ml/min/1.72m².
• Cardiac Conditions: History of flash pulmonary edema or amyloid cardiomyopathy.
• Breastfeeding: Female participants who are breastfeeding.
• Recent Participation in Clinical Trials: Participation in another clinical trial within the last three months prior to randomization.
• Requirements for treatment with a non-steroidal anti-inflammatory drug (except for Aspirin up to 200 mg as PRN daily).
• Serum potassium concentration <3.5 or >5.5 mmol/L.

Where it is running

• Future Life Clinical Trials — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.