Phase 3 N=2,859 Randomized Treatment

TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT03296813 ↗

Enrolled (actual)

2,859

Serious AEs

—

Results posted

Oct 2025

Primary outcome: Primary: All-cause Mortality, as Measured by Follow-up Phone Call or NDI — 373; 374 Participants — p=0.765

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Torsemide (Drug); Furosemide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY All-cause Mortality, as Measured by Follow-up Phone Call or NDI	373; 374	0.765
SECONDARY All-cause Mortality or All-cause Hospitalization, as Measured by Follow-up Phone Call or NDI (for Death)	149; 157	0.610
SECONDARY Total Re-hospitalizations, as Measured by Follow-up Phone Call	940; 987	0.366
SECONDARY All-cause Mortality or All-cause Hospitalization, as Measured by Follow-up Phone Call or NDI (for Death)	149; 157	0.610
SECONDARY Change in Health-related Quality of Life (QOL), as Measured by Follow-up Phone Call	69.52; 68.22; 70.61; 71.01; 70.00; 69.98	0.194
SECONDARY Symptoms of Depression as Measured by the Patient Health Questionnaire-2 (PHQ-2)	790; 813; 148; 150; 658; 672	0.904

Summary

TRANSFORM-HF is a large-scale, pragmatic, randomized, unblinded clinical effectiveness study comparing torsemide versus furosemide as treatment for heart failure. Approximately 6,000 patients with heart failure will be enrolled. The primary objective of the TRANSFORM-HF study is to compare the treatment strategy of torsemide versus furosemide on clinical outcomes over 12 months in patients with heart failure who are hospitalized.

Eligibility Criteria

Inclusion Criteria

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 one of the following criteria:
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)
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 (with most recent value used to determine eligibility)
Plan for a daily outpatient oral loop diuretic regimen upon hospital discharge with anticipated need for long-term loop diuretic use
≥ 18 years of age
Signed informed consent

Exclusion Criteria

End-stage renal disease requiring renal replacement 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
Malignancy or other non-cardiac condition limiting life expectancy to <12 months
Known hypersensitivity to furosemide, torsemide, or related agents

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03296813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.