NCT03296813

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

Official Title:

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

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

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 one 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 (with most recent value used to determine eligibility)
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 renal replacement 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
6. Malignancy or other non-cardiac condition limiting life expectancy to \<12 months
7. Known hypersensitivity to furosemide, torsemide, or related agents

Disease(s) and\or Condition(s)

Heart Failure

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: Torsemide
    • Description: Loop diuretic
    • Arm Group Labels: Torsemide
    • Type: DRUG
    • Name: Furosemide
    • Description: Loop diuretic
    • Arm Group Labels: Furosemide
Sponsor
  • Duke University