Torsemide Comparison With Furosemide for Management of Patients With Stable Heart Failure (TFO)
Primary Purpose
Heart Failure
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Furosemide
Torsemide
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Furosemide
Torsemide
Arm Description
Furosemide, oral, dosage and frequency determined by treating physician or provider. 1 mg torsemide to 2-4 mg oral furosemide
Torsemide, oral, dosage and frequency determined by treating physician or provider. 1 mg torsemide to 2-4 mg oral furosemide
Outcomes
Primary Outcome Measures
All-cause mortality, measured at 1 year.
All-cause mortality as measured by phone calls at 30 days and 1 year
Secondary Outcome Measures
All-cause hospitalization
All-cause hospitalization over one year
Total hospitalizations
• Total hospitalizations over one year
Change in weight
Change in weight over one year
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05093621
Brief Title
Torsemide Comparison With Furosemide for Management of Patients With Stable Heart Failure
Acronym
TFO
Official Title
Torsemide Comparison With Furosemide for Management of Patients With Stable Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
August 14, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Furosemide
Arm Type
Active Comparator
Arm Description
Furosemide, oral, dosage and frequency determined by treating physician or provider.
1 mg torsemide to 2-4 mg oral furosemide
Arm Title
Torsemide
Arm Type
Active Comparator
Arm Description
Torsemide, oral, dosage and frequency determined by treating physician or provider.
1 mg torsemide to 2-4 mg oral furosemide
Intervention Type
Drug
Intervention Name(s)
Furosemide
Intervention Description
Standard of care diuretic
Intervention Type
Drug
Intervention Name(s)
Torsemide
Intervention Description
Standard of care diuretic
Primary Outcome Measure Information:
Title
All-cause mortality, measured at 1 year.
Description
All-cause mortality as measured by phone calls at 30 days and 1 year
Time Frame
One year
Secondary Outcome Measure Information:
Title
All-cause hospitalization
Description
All-cause hospitalization over one year
Time Frame
One year
Title
Total hospitalizations
Description
• Total hospitalizations over one year
Time Frame
One year
Title
Change in weight
Description
Change in weight over one year
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Torsemide Comparison With Furosemide for Management of Patients With Stable Heart Failure
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