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

NCT06995144 | Completed Phase 4 FDA Drug

• 1 other identifier: SAR-2025-019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Edema; Pulmonary Congestion; Fluid Overload

Keywords

heart failure; natriuretic; torsemide; Soaanz; extended release; diuretic; sodium retention; water retention; renal clearance; low-sodium; diet; prolonged diuretic action; loop diuretic; urinary sodium excretion; furosemide; bumetanide; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Urinary sodium excretion measurement

  Urinary sodium excretion (mmol) measured after dosing: 4-8 hours (post-lunch period)

  4-8 hours (post-lunch period)

Secondary Outcomes (1)

• Urinary sodium excretion

  0-4 hours (pre-lunch period) and 8-24 hours (post-lunch period)

Study Arms (2)

Arm 1 IR torsemide

ACTIVE COMPARATOR

Approximately half of the participants will receive 20 mg IR torsemide followed by 24 mg ER torsemide or 40mg IR torsemide followed by 48 mg ER torsemide (6-10 days each)

Drug: Extended Release Torsemide Tablets; Drug: Immedate Release Torsemide Tablets

ARM 2 ER torsemide

ACTIVE COMPARATOR

The other half will receive 24 mg ER torsemide followed by 20 mg IR torsemide, or 48 mg ER torsemide followed by 40 mg IR torsemide (6-10 days each)

Drug: Extended Release Torsemide Tablets; Drug: Immedate Release Torsemide Tablets

Interventions

Immedate Release Torsemide Tablets DRUG

Immediate release torsemide vs Extended release torsemide

Also known as: IR Torsemide Tablets

ARM 2 ER torsemide; Arm 1 IR torsemide

Extended Release Torsemide Tablets DRUG

Extended release torsemide vs Immediate release torsemide

Also known as: ER Torsemide tablets

ARM 2 ER torsemide; Arm 1 IR torsemide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sarfez Pharmaceuticals, Inc.: lead

Study Sites (1)

Future Life Clinical Trials

Miami, Florida, 33169, United States

Location

MeSH Terms

Conditions

Heart Failure; Edema; Hypernatremia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Salim Shah, PhD, JD

  Sarfez Pharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 29, 2025
• Study Start: May 28, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (1)