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

Phase 3

Completed

Conditions: Heart Failure

Interventions: Drug: Furosemide
Drug: Torsemide

Registration Number: NCT05093621

Lead Sponsor: Yale University

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, NCT03296813.

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, NCT03296813) a mechanistic sub-study of this study and TRANSFORMHF.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 47

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants All-cause Mortality, Measured at 1 Year.	30 days and one year	All-cause mortality as measured by phone calls at 30 days and 1 year

Secondary Outcome Measures

Name	Time	Method
All-cause Hospitalization	up to one year	At least one hospitalization for any reason up to one year
Total Hospitalizations	up to one year	Total number of hospitalizations total number of hospitalizations in one year
Change in Weight	up to one year	Change in weight up to one year