Torsemide Comparison With Furosemide for Management of Patients With Stable Heart Failure

NCT05093621 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 2000029589
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to be a prospective, randomized study is to compare the effectiveness of two standard of care loop diuretics (furosemide versus torsemide) on clinical outcomes among patients currently on a stable dose of loop diuretics.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Number of Participants All-cause Mortality, Measured at 1 Year.

  All-cause mortality as measured by phone calls at 30 days and 1 year

  30 days and one year

Secondary Outcomes (3)

• All-cause Hospitalization

  up to one year

• Total Hospitalizations

  up to one year

• Change in Weight

  up to one year

Study Arms (2)

Furosemide

ACTIVE COMPARATOR

Furosemide, oral, dosage and frequency determined by treating physician or provider. 1 mg torsemide to 2-4 mg oral furosemide

Drug: Furosemide

Torsemide

ACTIVE COMPARATOR

Torsemide, oral, dosage and frequency determined by treating physician or provider. 1 mg torsemide to 2-4 mg oral furosemide

Drug: Torsemide

Interventions

Furosemide DRUG

Standard of care diuretic

Furosemide

Torsemide DRUG

Standard of care diuretic

Torsemide

Eligibility Criteria

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

You may qualify if:

• Patients with a diagnosis of heart failure and who have been on a stable dose of a diuretic for at least 30 days.
• Plan for a daily outpatient oral loop diuretic regimen with anticipated need for long term loop diuretic use
• ≥ 18 years of age
• Signed informed consent

You may not qualify if:

• End-stage renal disease requiring dialysis therapy
• Inability or unwillingness to comply with the study requirements
• History of heart transplant or actively listed for heart transplant
• Implanted left ventricular assist device or implant anticipated \<3 months
• Pregnant or nursing women or women who are trying to conceive
• Malignancy or other non-cardiac condition limiting life expectancy to \<12 months
• Known hypersensitivity to furosemide, torsemide, or related agents

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• Rao VS, Cox ZL, Ivey-Miranda JB, Neville D, Balkcom N, Moreno-Villagomez J, Ramos-Mastache D, Maulion C, Bellumkonda L, Tang WHW, Collins SP, Velazquez EJ, Mentz RJ, Wilson FP, Turner JM, Wilcox CS, Ellison DH, Fang JC, Testani JM. Mechanistic Differences between Torsemide and Furosemide. J Am Soc Nephrol. 2025 Jan 1;36(1):99-107. doi: 10.1681/ASN.0000000000000481. Epub 2024 Aug 28.

  PMID: 39196651 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Furosemide; Torsemide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jeffrey Testani, MD, MTR Associate Professor of Medicine
• Organization: Yale School of Medicine

jeffrey.testani@yale.edu

(203) 785-7191

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 26, 2021
• Study Start: February 8, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)