TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure
NCT ID: NCT03296813
Last Updated: 2025-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2973 participants
INTERVENTIONAL
2018-07-11
2022-07-29
Brief Summary
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Detailed Description
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* Trial enrollment occurs before hospital discharge, at the discretion of the healthcare provider.
* As appropriate, adherence to the randomized medication will be encouraged during the remainder of hospitalization and will continue post-discharge. Patients will receive follow-up per standard care without any additional study-specific visits.
* Patients will have 30-day, 6-month and 12-month follow-up phone contacts for assessments of vital status, interval hospitalizations, adherence, and quality of life. "Central follow-up" and collection of hospital discharge summaries via IRB-approved mechanisms. Subsets of patients enrolled early in the study have additional phone contacts beyond 12 months, up to 30 months, at six month intervals, to document vital status.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Torsemide
Oral dosing of torsemide compared to furosemide will be 1mg:2-4mg.
Torsemide
Loop diuretic
Furosemide
Oral dosing of torsemide compared to furosemide will be 1mg:2-4mg.
For patients receiving loop diuretics other than furosemide, conversion to furosemide equivalents will be as follows:
1 mg oral torsemide = 2-4 mg oral furosemide
1 mg oral or intravenous bumetanide = 40 mg oral furosemide
Furosemide
Loop diuretic
Interventions
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Torsemide
Loop diuretic
Furosemide
Loop diuretic
Eligibility Criteria
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Inclusion 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
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
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Yale University
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Eric Velazquez, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Robert Mentz, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Russel Medical Center
Alexander City, Alabama, United States
The Heart Center, PC
Huntsville, Alabama, United States
University of Arizona
Tucson, Arizona, United States
V.A. Greater Los Angeles Healthcare System
Los Angeles, California, United States
Kaiser Permanente Medical Center
San Francisco, California, United States
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Yale
New Haven, Connecticut, United States
West Haven VA Medical Center
West Haven, Connecticut, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
University of Florida - Gainesville
Gainesville, Florida, United States
Emory Health Care
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Queens Medical Center
Honolulu, Hawaii, United States
Fox Valley Clinical Research Center
Aurora, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Indiana University Health Bloomington Hospital
Bloomington, Indiana, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University Medical Center
New Orleans, Louisiana, United States
Oschner Clinic
New Orleans, Louisiana, United States
VA Medical Center/University of Maryland
Baltimore, Maryland, United States
Shady Grove Medical Center
Rockville, Maryland, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Saint Joseph Mercy Health System / Michigan Heart
Ypsilanti, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Lester E. Cox Health Systems
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States
Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Weill Cornell Medical College
New York, New York, United States
Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Montefore Medical Center - Albert Einstein University Hospital
The Bronx, New York, United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States
Duke (Duke Heart Center)
Durham, North Carolina, United States
Novant Health Matthews Medical Center
Matthews, North Carolina, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Good Samaritan Hospital
Ephrata, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Main Line Health System
Wynnewood, Pennsylvania, United States
Greenville Hospital System University Medical Center
Greenville, South Carolina, United States
Black Hills Cardiovascular Research
Rapid City, South Dakota, United States
Baylor University Medical Center
Dallas, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States
Inova Health Care Services
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Commonwealth University Health
Richmond, Virginia, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States
Countries
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References
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Rao VS, Cox ZL, Ivey-Miranda JB, Neville D, Balkcom N, Moreno-Villagomez J, Ramos-Mastache D, Maulion C, Bellumkonda L, Tang WHW, Collins SP, Velazquez EJ, Mentz RJ, Wilson FP, Turner JM, Wilcox CS, Ellison DH, Fang JC, Testani JM. Mechanistic Differences between Torsemide and Furosemide. J Am Soc Nephrol. 2025 Jan 1;36(1):99-107. doi: 10.1681/ASN.0000000000000481. Epub 2024 Aug 28.
Kittipibul V, Mentz RJ, Clare RM, Wojdyla DM, Anstrom KJ, Eisenstein EL, Ambrosy AP, Goyal P, Skopicki HA, Ketema F, Kim DY, Desvigne-Nickens P, Pitt B, Velazquez EJ, Greene SJ. On-treatment analysis of torsemide versus furosemide for patients hospitalized for heart failure: A post-hoc analysis of TRANSFORM-HF. Eur J Heart Fail. 2024 Jul;26(7):1518-1523. doi: 10.1002/ejhf.3293. Epub 2024 May 15.
Kapelios CJ, Greene SJ, Mentz RJ, Ikeaba U, Wojdyla D, Anstrom KJ, Eisenstein EL, Pitt B, Velazquez EJ, Fang JC; TRANSFORM-HF Investigators. Torsemide Versus Furosemide After Discharge in Patients Hospitalized With Heart Failure Across the Spectrum of Ejection Fraction: Findings From TRANSFORM-HF. Circ Heart Fail. 2024 Mar;17(3):e011246. doi: 10.1161/CIRCHEARTFAILURE.123.011246. Epub 2024 Mar 4.
Greene SJ, Velazquez EJ, Anstrom KJ, Clare RM, DeWald TA, Psotka MA, Ambrosy AP, Stevens GR, Rommel JJ, Alexy T, Ketema F, Kim DY, Desvigne-Nickens P, Pitt B, Eisenstein EL, Mentz RJ; TRANSFORM-HF Investigators. Effect of Torsemide Versus Furosemide on Symptoms and Quality of Life Among Patients Hospitalized for Heart Failure: The TRANSFORM-HF Randomized Clinical Trial. Circulation. 2023 Jul 11;148(2):124-134. doi: 10.1161/CIRCULATIONAHA.123.064842. Epub 2023 May 22.
Mentz RJ, Anstrom KJ, Eisenstein EL, Sapp S, Greene SJ, Morgan S, Testani JM, Harrington AH, Sachdev V, Ketema F, Kim DY, Desvigne-Nickens P, Pitt B, Velazquez EJ; TRANSFORM-HF Investigators. Effect of Torsemide vs Furosemide After Discharge on All-Cause Mortality in Patients Hospitalized With Heart Failure: The TRANSFORM-HF Randomized Clinical Trial. JAMA. 2023 Jan 17;329(3):214-223. doi: 10.1001/jama.2022.23924.
Eisenstein EL, Sapp S, Harding T, Harrington A, Velazquez EJ, Mentz RJ, Greene SJ, Sachdev V, Kim DY, Anstrom KJ. Ascertaining Death Events in a Pragmatic Clinical Trial: Insights From the TRANSFORM-HF Trial. J Card Fail. 2022 Oct;28(10):1563-1567. doi: 10.1016/j.cardfail.2022.01.020. Epub 2022 Feb 16.
Greene SJ, Velazquez EJ, Anstrom KJ, Eisenstein EL, Sapp S, Morgan S, Harding T, Sachdev V, Ketema F, Kim DY, Desvigne-Nickens P, Pitt B, Mentz RJ; TRANSFORM-HF Investigators. Pragmatic Design of Randomized Clinical Trials for Heart Failure: Rationale and Design of the TRANSFORM-HF Trial. JACC Heart Fail. 2021 May;9(5):325-335. doi: 10.1016/j.jchf.2021.01.013. Epub 2021 Mar 10.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Related Info
Other Identifiers
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Pro00080595
Identifier Type: -
Identifier Source: org_study_id
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