NCT06995144WithdrawnPhase 4
Comparing Natriuretic Effects of ER Torsemide to IR Torsemide in Patients With Heart Failure
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)
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 16 May 2025
- Start date
- May 2025
- Primary completion date
- 16 Sept 2026
- Lead sponsor
- Sarfez Pharmaceuticals, Inc.
- Diseases
- Heart failure, Chronic kidney disease
- NCT number
- NCT06995144
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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).
Other illness
- 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.
- Cardiac Conditions: History of flash pulmonary edema or amyloid cardiomyopathy.
Lab values
- Renal Dysfunction: Estimated GFR < 30 ml/min/1.72m².
- Serum potassium concentration <3.5 or >5.5 mmol/L.
Other
- Breastfeeding: Female participants who are breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Future Life Clinical Trials | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.