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Heart FailurePhase 3TRANSFORM-HFNCT03296813

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

A Phase 3 study testing Torsemide and Furosemide in people with Heart Failure, run by Duke University at 60 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Torsemide and Furosemide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,973 participants
Where
60 sitesUnited States
Study dates
11 Jul 2018to 29 Jul 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

United States60 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Russel Medical Center

    Alexander City, Alabama, 35010

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • Emory Health Care

    Atlanta, Georgia, 30322

  • Augusta University

    Augusta, Georgia, 30912

  • Fox Valley Clinical Research Center

    Aurora, Illinois, 60506

  • VA Medical Center/University of Maryland

    Baltimore, Maryland, 21201

  • Indiana University Health Bloomington Hospital

    Bloomington, Indiana, 47402

  • Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • University of North Carolina School of Medicine

    Chapel Hill, North Carolina, 27514

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke (Duke Heart Center)

    Durham, North Carolina, 27710

  • Good Samaritan Hospital

    Ephrata, Pennsylvania, 17522

  • Inova Health Care Services

    Falls Church, Virginia, 22042

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • University of Florida - Gainesville

    Gainesville, Florida, 32610

  • Greenville Hospital System University Medical Center

    Greenville, South Carolina, 29605

  • Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Queens Medical Center

    Honolulu, Hawaii, 96813

  • The Heart Center, PC

    Huntsville, Alabama, 35801

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 29216

  • V.A. Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Novant Health Matthews Medical Center

    Matthews, North Carolina, 28240

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Yale

    New Haven, Connecticut, 06511

  • University Medical Center

    New Orleans, Louisiana, 70112

  • Oschner Clinic

    New Orleans, Louisiana, 70121

  • Weill Cornell Medical College

    New York, New York, 10021

  • Mount Sinai

    New York, New York, 10029-6574

  • Columbia University Medical Center

    New York, New York, 10032

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61606

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • AtlantiCare Regional Medical Center

    Pomona, New Jersey, 08240

  • Black Hills Cardiovascular Research

    Rapid City, South Dakota, 57701

  • Virginia Commonwealth University Health

    Richmond, Virginia, 23298

  • Shady Grove Medical Center

    Rockville, Maryland, 20850

  • University of Utah Hospitals and Clinics

    Salt Lake City, Utah, 84132

  • Kaiser Permanente Medical Center

    San Francisco, California, 94115

  • Lester E. Cox Health Systems

    Springfield, Missouri, 65807

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Montefore Medical Center - Albert Einstein University Hospital

    The Bronx, New York, 10461

  • University of Arizona

    Tucson, Arizona, 85724

  • West Haven VA Medical Center

    West Haven, Connecticut, 06516

  • New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401

  • Main Line Health System

    Wynnewood, Pennsylvania, 19096

  • Saint Joseph Mercy Health System / Michigan Heart

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

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.

Read the 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. Patients will be randomized 1:1 to either oral torsemide OR oral furosemide prior to hospital discharge. Oral dosing of torsemide compared to furosemide will be 1mg:2mg. The specific loop diuretic dose will be at the discretion of the treating physician with the above noted conversion.
  • 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
Heart Failure
Being tested
Torsemide, Furosemide
Keywords
loop diuretic
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TorsemideDrug

    Loop diuretic

  • FurosemideDrug

    Loop diuretic

Study groups in NCT03296813
Study groupRoleWhat they receive
TorsemideActive comparatorOral dosing of torsemide compared to furosemide will be 1mg:2-4mg.
Receives: Drug: Torsemide
FurosemideActive comparatorOral 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
Receives: Drug: Furosemide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause Mortality, as Measured by Follow-up Phone Call or NDI

    Death information was obtained from the Call Center through 30 months for patients 1-500, through 24 months for patients 501-1000, through 18 months for patients 1001-1500, and through 12 months for the remaining patients (except those who were randomized < 12 months when the study was stopped by the DSMB). Also death information was obtained through searches of the 2018-2021 National Death Index (NDI) database.

    Measured: up to 30 months

Secondary outcomes (5)

  1. All-cause Mortality or All-cause Hospitalization, as Measured by Follow-up Phone Call or NDI (for Death)

    The time-to-event analysis of all-cause mortality or all-cause primary re-hospitalization was based on the time from randomization through death or the first primary re-hospitalization through 12 months. Patients who died or whose first all-cause re-hospitalization was after month 12 were censored at month 12. Patients who did not have a re-hospitalization and were alive were censored at the minimum of the time of the last re-hospitalization assessment or month 12.

    Measured: up to 12 months

  2. Total Re-hospitalizations, as Measured by Follow-up Phone Call

    Total all-cause primary re-hospitalization was defined as a hospitalization after the index hospitalization through month 12 that met one of the following criteria: 1.) at least a 24-hour stay (or a change in calendar date if the time of admission/discharge is not available) or 2.) reported as an in-patient admission by the patient/proxy with an admission date (complete or month and year) and no discharge date (i.e., length of stay could not be derived). Unit of measurement is the total number of re-hospitalizations for each subject (e.g., if a subject had 3 re-hospitalizations, then the outcome is 3 for the subject).

    Measured: up to 12 months

  3. All-cause Mortality or All-cause Hospitalization, as Measured by Follow-up Phone Call or NDI (for Death)

    All-cause mortality or all-cause hospitalization over 30 days

    Measured: 30 days

  4. Change in Health-related Quality of Life (QOL), as Measured by Follow-up Phone Call

    QOL as assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) (range, 0-100 with 100 indicating best health status). The KCCQ was administered prior to randomization (collected by the site) and at Months 1, 6 and 12 (ascertained at the Call Center visits). The outcome is the least square means in Torsemide and Furosemide groups where the difference = Torsemide mean minus Furosemide mean at the monthly assessment.

    Measured: Baseline, 1 month, 6 months, 12 months

  5. Symptoms of Depression as Measured by the Patient Health Questionnaire-2 (PHQ-2)

    Depression was assessed by the Patient Health Questionnaire-2 (PHQ-2) over 12 months. The PHQ-2 inquires about the frequency of depressed mood and anhedonia (inability to feel pleasure) over the past two weeks. The responses to the questions are scored 0 = Not at all, 1 = Several days, 2 = More than half the days, and 3 = Nearly every day. The PHQ-2 total score is obtained by adding the score for each question. The PHQ-2 total score ranges from 0-6. Reported as the number of patients with a total score <3 versus >=3.

    Measured: Month 1, month 6, month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2017
  2. Study start11 Jul 2018
  3. Primary completion29 Jul 2022
  4. Study completion29 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will be a randomized, unblinded, two-arm, multi-center clinical trial of patients with heart failure who are hospitalized. Patients will be randomized 1:1 to either oral torsemide OR oral furosemide prior to hospital discharge.
Masking
None (open label)
Enrolment
2,973 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03296813
Sponsor's protocol ID
Pro00080595
Other IDs
U01HL125511-01A1
Acronym
TRANSFORM-HF
Status last verified
Sep 2025
First submitted
26 Sep 2017
Last updated
16 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tong G, Zeng Y, Greene SJ, Anstrom KJ, Testani J, Mentz RJ, Li F, Velazquez EJ. Comparative effectiveness of torsemide vs furosemide in the management of heart failure patients: Win-ratio reanalysis of the TRANSFORM-HF trial. Am Heart J. 2026 Jul 8;301:107525. doi: 10.1016/j.ahj.2026.107525. Online ahead of print.

    PubMed 42419438

  • 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.

    PubMed 39196651

  • 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.

    PubMed 38745502

  • 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.

    PubMed 38436075

  • 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.

    PubMed 37212600

  • 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.

    PubMed 36648467

  • 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.

    PubMed 35181553

  • 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.

    PubMed 33714745

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Torsemide and Furosemide in people with Heart Failure, run by Duke University at 60 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality, as Measured by Follow-up Phone Call or NDI (time frame: up to 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03296813, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.

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