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

Launched by SARFEZ PHARMACEUTICALS, INC. · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different forms of a medication called torsemide, which is used to help patients with heart failure by getting rid of excess fluid in the body. The goal is to see if taking a morning dose of extended-release torsemide leads to better kidney function in removing sodium (a type of salt) from the body after lunch, compared to immediate-release torsemide. Participants will switch from their current diuretic medication to either the extended-release or immediate-release version for a week, and then their sodium levels in urine will be measured at different times throughout the day.

To be eligible for the study, participants must be at least 18 years old and have been diagnosed with stable chronic heart failure for at least a month. They should also be taking a specific dose of a diuretic medication regularly. Participants will be monitored during the study, and they will need to provide urine samples to track how well their bodies are responding to the medication. This research is important as it may help improve treatment options for patients with heart failure in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.