Overview
TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure
Status:
Recruiting
Recruiting
Trial end date:
2022-08-14
2022-08-14
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Duke UniversityCollaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Yale UniversityTreatments:
Diuretics
Furosemide
Sodium Potassium Chloride Symporter Inhibitors
Torsemide
Criteria
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