A Crossover Study of Patients With HF to Compare Natriuretic Effects of IR Torsemide vs. ER Torsemide Over 12 Hrs (EXTOR-HF)

A Crossover Study to Compare Natriuretic Effects of Extended Release Torsemide to Immediate Release Torsemide Over 12 Hours After Dosing in Patients With Heart Failure (EXTOR-HF)

This is a randomized double-blind crossover study of the patients with stable heart failure, who are taking a loop diuretic. During the study period, the participants' loop diuretics will be replaced by the equivalent dose of immediate release/extended release torsemide for one week. After a one week period, they will report to the site and will receive a single dose of either immediate release or extended release Torsemide. The sodium excretion will be measured for six hours after dosing and for an additional six hours after a high salt lunch.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure
• Intervention / Treatment: Drug: torsemide

Detailed Description

The goal of this randomized double-blind crossover study is to assess whether extended release torsemide has a better efficacy than immediate release torsemide to induce renal sodium excretion after a salty lunch in patients with heart failure. The study will address if:

• the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a morning dose of extended release torsemide is different from the amounts after the immediate release torsemide.
• the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, is different from the amounts after the immediate release torsemide.
• the amount of excreted sodium in the urine during the 24 hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, is different from the amount after the immediate release torsemide.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33169
      • Future Life Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Man or woman over the age of 18 years.
• Willing and able to sign the informed consent.
• A clinical diagnosis of chronic HF that is considered by patient's cardiologist/physician or an experienced clinician to be stable over the one-month period prior to randomization.
• Receiving oral furosemide (or equivalent doses of torsemide or bumetanide) for about 30 days prior to randomization.
• No anticipated changes in HF medications during the study period.
• Premenopausal women of child-bearing potential have a negative pregnancy test prior to beginning of the study and agree to use effective contraceptive methods during the study period

Exclusion Criteria:

• Requirement for a diuretic other than furosemide, bumetanide or torsemide except for spironolactone, eplerenone, finerenone, or SGLT2 inhibitors, at randomization and during the study.
• Myocardial infarction, stroke, transient ischemic attack, acute kidney injury or acute HF requiring admission to hospital within the last 30 days prior to randomization.
• Severe / symptomatic lung disease or respiratory symptoms distinct from HF.
• Urinary incontinence or inability to empty bladder.
• Uncontrolled diabetes mellitus or uncontrolled hypertension.
• Estimated GFR < 30 ml/min/1.72m2.
• History of flash pulmonary edema or amyloid cardiomyopathy.
• Female patients who are breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extended release torsemide; Drug: Extended release torsemide 24 mg tablet. Subjects will receive oral dose of 24 mg extended release torsemide tablet and a placebo of 20 mg immediate release torsemide.	Drug: torsemide; Extended release formulation of torsemide
Active Comparator: Immediate release torsemide; Drug: Immediate release torsemide 20 mg tablet. Subjects will receive oral dose of 20 mg of immediate release torsemide and a placebo of 24 mg extended release torsemide.	Drug: torsemide; Extended release formulation of torsemide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Na+ excretion over 6 hours	The primary outcome is the cumulative Na+ excretion over 6 hours after lunch.	6 hours after lunch

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
K+ excretion	Safety outcome	While in the study (approximately 2 weeks)
Fluid and Na+ excretion over the 6 hours	Fluid and Na+ excretion over the 6 hours after breakfast, 6 hours after lunch, and 24 hours after dosing.	6 hours after breakfast, 6 hours after lunch, and 24 hours]
Creatinine clearance	Safety outcome	While in the study (approximately 2 weeks)

Collaborators and Investigators

• Sponsor: Sarfez Pharmaceuticals, Inc.
• Investigators: Study Director: Sophia Shah, MD, Safez Pharmaceuticals; Principal Investigator: Nayle A Ancares, MD, Future Life Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Actual): March 25, 2025
• Study Completion (Actual): March 25, 2025

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: November 24, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amides; Sulfonamides; Sulfones; Torsemide
• Other Study ID Numbers: SAR065-324

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No