Status:
COMPLETED
TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Yale University
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 hea...
Detailed Description
* This study will be a randomized, unblinded, two-arm, multi-center clinical trial of patients with heart failure who are hospitalized. Heart failure need not be the reason for hospitalization. Patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2022
Estimated Enrollment :
2973 Patients enrolled
Trial Details
Trial ID
NCT03296813
Start Date
July 11 2018
End Date
July 29 2022
Last Update
October 16 2025
Active Locations (60)
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1
Russel Medical Center
Alexander City, Alabama, United States, 35010
2
The Heart Center, PC
Huntsville, Alabama, United States, 35801
3
University of Arizona
Tucson, Arizona, United States, 85724
4
V.A. Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073