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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
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
October 13, 2021
Last Updated
September 26, 2023
Sponsor
Yale University
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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

Learn more about this trial

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

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