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

NCT06708611 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: SAR065-324
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Cumulative Na+ excretion over 6 hours

  The primary outcome is the cumulative Na+ excretion over 6 hours after lunch.

  6 hours after lunch

Secondary Outcomes (3)

• Fluid and Na+ excretion over the 6 hours

  6 hours after breakfast, 6 hours after lunch, and 24 hours]

• Creatinine clearance

  While in the study (approximately 2 weeks)

• K+ excretion

  While in the study (approximately 2 weeks)

Study Arms (2)

Extended release torsemide

EXPERIMENTAL

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

Immediate release torsemide

ACTIVE COMPARATOR

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

Interventions

torsemide DRUG

Extended release formulation of torsemide

Extended release torsemide; Immediate release torsemide

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sarfez Pharmaceuticals, Inc.: lead

Study Sites (1)

Future Life Clinical Trials

Miami, Florida, 33169, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Torsemide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sophia Shah, MD

  Safez Pharmaceuticals

  STUDY DIRECTOR

• Nayle A Ancares, MD

  Future Life Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, double-dummy, two-period, two arm, randomized, crossover clinical trial.

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: January 15, 2025
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)