Comparing effects of two forms of torsemide in heart failure patients
A Randomized, Two-Period, Two-Arm, Double-Dummy, Crossover Study to Compare Natriuretic Effects of Extended Release Torsemide to Immediate Release Torsemide in Patients With Heart Failure (NEXT-HF)
This study is testing if a long-lasting version of torsemide helps heart failure patients get rid of more sodium in their urine compared to the regular version.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sarfez Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06995144 on ClinicalTrials.gov |
What this trial studies
This study aims to determine whether extended-release torsemide leads to greater renal sodium excretion compared to immediate-release torsemide in patients with stable heart failure. It is a randomized, double-blind, crossover study where participants will receive both formulations of torsemide after a stabilization period on their current diuretic therapy. Urine samples will be collected at various intervals post-dosing to assess sodium excretion. The study will involve a careful dose conversion for participants currently on other loop diuretics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a stable diagnosis of chronic heart failure who are currently on a loop diuretic.
Not a fit: Patients requiring diuretics other than furosemide, bumetanide, or torsemide may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective diuretic option for heart failure patients, potentially improving their fluid management.
How similar studies have performed: While this approach is novel in comparing these specific formulations of torsemide, similar studies have shown promise in optimizing diuretic therapy for heart failure.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida
- Future Life Clinical Trials — Miami, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Chris Wilcox, MD, PhD
- Email: wilcoxch@georgetown.edu
- Phone: 703-627-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.