TRANSFORM-HF

Brief Summary

Primary Objective

The primary objective of the TRANSFORM-HF study is to compare the treatment strategy of torsemide versus furosemide on long-term clinical outcomes among patients hospitalized for heart failure. All patients will be followed for a minimum of 12 months.

Our primary hypothesis is that torsemide will reduce all-cause mortality by a relative 20% (i.e. a hazard ratio of 0.80) compared to furosemide. This is an event-driven trial that will require at least 721 primary endpoint events to have ≥ 85% power.

Secondary Objectives

Other secondary objectives of this protocol will be to examine the effect of torsemide versus furosemide for the following endpoints:

• All-cause mortality or all-cause hospitalization over 12 months
• Total hospitalizations over 12 months
• All-cause mortality or all-cause hospitalization over 30 days
• Health-related quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), over 12 months
• Symptoms of depression, as measured by the Patient Health Questionnaire-2 (PHQ-2), over 12 months

Inclusion Criteria

1. Patient hospitalized (≥ 24 hours or over a change in calendar date) with worsening of chronic heart failure, or new diagnosis of heart failure AND meets 1 of the following criteria:
   1. Has a left ventricular ejection fraction (EF) ≤40% within 24 months prior to and including index hospitalization by any method (with most recent value used to determine eligibility)
   2. Has an elevated natriuretic peptide level (either NT-pro-B-type natriuretic peptide or B-type natriuretic peptide) during index hospitalization as measured by local laboratory
2. Plan for a daily outpatient oral loop diuretic regimen upon hospital discharge 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