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

Heart Failure Clinical Trial

— TFO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05093621
• Other study ID #: 2000029589
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 8, 2021
• Est. completion date: August 14, 2024

Study information

• Verified date: September 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will be a randomized, unblinded, two-arm, multi-center clinical trial of patients receiving loop diuretics for treatment of heart failure in an outpatient clinic. This study will serve as additional enrollment for Cardio-Renal Effects of Torsemide vs. Furosemide: A TRANSFORMHF Mechanistic Sub-Study (HIC 2000025867) which is currently only enrolling patients admitted to the hospital for worsening heart failure. Thus allowing for expanded enrollment into HIC 2000025867 with a more diverse group of heart failure patients. Participants will be co-enrolled into this study and HIC 2000025867. Patients will be randomized 1:1 to either oral torsemide OR oral furosemide (dosing at discretion of local provider with dose equivalency guidance provided). This study will include stable subjects seen at the outpatient setting. The initial and follow-up dosing of torsemide and furosemide will be at healthcare provider discretion, with the following conversion provided as a guide: 1 mg torsemide to 2-4 mg oral furosemide. For instance, a patient would receive torsemide 20mg or furosemide 40-80 mg. Providers will be asked to document their planned initial dose and dosing frequency of torsemide and furosemide Randomization will occur within thirty days after the consent process and at the discretion of the healthcare provider and research team. Following randomization, the study medication is expected to constitute the oral diuretic therapy for one year. Patients will be prescribed the randomized study medication on the day of randomization. Dose adjustments will be at the discretion of the treating healthcare provider(s) with strategies in place to maintain prescription of and adherence to the randomized medication. All patients will have 30-day, and 12-month post-randomization phone contacts for assessment of vital status, interval hospitalizations, concomitant HF medications, adherence, and weight. To achieve these goals, the investigators propose a multi-center 125-patient study that will also co-enroll into Transform Ancillary (HIC 2000025867) a mechanistic sub-study of this study and TRANSFORMHF.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: August 14, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with a diagnosis of heart failure and who have been on a stable dose of a diuretic for at least 30 days.

2. Plan for a daily outpatient oral loop diuretic regimen with anticipated need for long term loop diuretic use

3. = 18 years of age

4. Signed informed consent

Exclusion Criteria:

1. End-stage renal disease requiring dialysis therapy

2. Inability or unwillingness to comply with the study requirements

3. History of heart transplant or actively listed for heart transplant

4. Implanted left ventricular assist device or implant anticipated <3 months

5. Pregnant or nursing women or women who are trying to conceive

6. Malignancy or other non-cardiac condition limiting life expectancy to <12 months

7. Known hypersensitivity to furosemide, torsemide, or related agents

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Furosemide
Standard of care diuretic
• Torsemide
Standard of care diuretic

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality, measured at 1 year.	All-cause mortality as measured by phone calls at 30 days and 1 year	One year
Secondary	All-cause hospitalization	All-cause hospitalization over one year	One year
Secondary	Total hospitalizations	• Total hospitalizations over one year	One year
Secondary	Change in weight	Change in weight over one year	One year