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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Torsemide
Furosemide
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring loop diuretic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Russel Medical Center
  • The Heart Center, PC
  • University of Arizona
  • V.A. Greater Los Angeles Healthcare System
  • Kaiser Permanente Medical Center
  • Saint Francis Hospital and Medical Center
  • Yale
  • West Haven VA Medical Center
  • Holy Cross Hospital
  • University of Florida - Gainesville
  • Emory Health Care
  • Augusta University
  • Queens Medical Center
  • Fox Valley Clinical Research Center
  • Northwestern Memorial Hospital
  • University of Chicago
  • Loyola University Medical Center
  • Methodist Medical Center of Illinois
  • Indiana University Health Bloomington Hospital
  • Indiana University Medical Center
  • University of Iowa Hospitals and Clinics
  • University Medical Center
  • Oschner Clinic
  • VA Medical Center/University of Maryland
  • Shady Grove Medical Center
  • University of Michigan Medical Center
  • Henry Ford Hospital
  • Saint Joseph Mercy Health System / Michigan Heart
  • University of Minnesota
  • University of Mississippi Medical Center
  • Washington University School of Medicine
  • Lester E. Cox Health Systems
  • AtlantiCare Regional Medical Center
  • Montefore Medical Center - Albert Einstein University Hospital
  • Presbyterian/Brooklyn Methodist Hospital
  • North Shore University Hospital
  • Weill Cornell Medical College
  • Mount Sinai
  • Columbia University Medical Center
  • Stony Brook University Hospital
  • University of North Carolina School of Medicine
  • Duke (Duke Heart Center)
  • Novant Health Matthews Medical Center
  • New Hanover Regional Medical Center
  • University Hospitals Case Medical Center
  • Cleveland Clinic
  • Abington Memorial Hospital
  • Good Samaritan Hospital
  • Drexel University College of Medicine
  • Jefferson University Hospital
  • Main Line Health System
  • Greenville Hospital System University Medical Center
  • Black Hills Cardiovascular Research
  • Baylor University Medical Center
  • Intermountain Medical Center
  • University of Utah Hospitals and Clinics
  • Inova Health Care Services
  • Sentara Norfolk General Hospital
  • Virginia Commonwealth University Health
  • Froedtert Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Torsemide

Furosemide

Arm Description

Oral dosing of torsemide compared to furosemide will be 1mg:2-4mg.

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

Outcomes

Primary Outcome Measures

All-cause mortality, as measured by follow-up phone call
All-cause mortality over a follow-up period of 12 months; subsets of patients to be evaluated at 6 month intervals to document vital status up to 30 months.

Secondary Outcome Measures

All-cause mortality or all-cause hospitalization, as measured by follow-up phone call
All-cause mortality or all-cause hospitalization over 12 months
Total hospitalizations, as measured by follow-up phone call
Total hospitalizations over 12 months
All-cause mortality or all-cause hospitalization, as measured by follow-up phone call
All-cause mortality or all-cause hospitalization over 30 days
Health-related quality of life, as measured by follow-up phone call
Health-related quality of life over 12 months
Symptoms of depression, as measured by follow-up phone call
Symptoms of depression over 12 months

Full Information

First Posted
September 26, 2017
Last Updated
August 17, 2022
Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03296813
Brief Title
TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure
Acronym
TRANSFORM-HF
Official Title
TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 11, 2018 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
July 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
loop diuretic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
2859 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Torsemide
Arm Type
Active Comparator
Arm Description
Oral dosing of torsemide compared to furosemide will be 1mg:2-4mg.
Arm Title
Furosemide
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Torsemide
Intervention Description
Loop diuretic
Intervention Type
Drug
Intervention Name(s)
Furosemide
Intervention Description
Loop diuretic
Primary Outcome Measure Information:
Title
All-cause mortality, as measured by follow-up phone call
Description
All-cause mortality over a follow-up period of 12 months; subsets of patients to be evaluated at 6 month intervals to document vital status up to 30 months.
Time Frame
30 months
Secondary Outcome Measure Information:
Title
All-cause mortality or all-cause hospitalization, as measured by follow-up phone call
Description
All-cause mortality or all-cause hospitalization over 12 months
Time Frame
12 months
Title
Total hospitalizations, as measured by follow-up phone call
Description
Total hospitalizations over 12 months
Time Frame
12 months
Title
All-cause mortality or all-cause hospitalization, as measured by follow-up phone call
Description
All-cause mortality or all-cause hospitalization over 30 days
Time Frame
30 days
Title
Health-related quality of life, as measured by follow-up phone call
Description
Health-related quality of life over 12 months
Time Frame
12 months
Title
Symptoms of depression, as measured by follow-up phone call
Description
Symptoms of depression over 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Velazquez, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Mentz, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Russel Medical Center
City
Alexander City
State/Province
Alabama
ZIP/Postal Code
35010
Country
United States
Facility Name
The Heart Center, PC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
V.A. Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Yale
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
West Haven VA Medical Center
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
University of Florida - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Emory Health Care
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Queens Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Fox Valley Clinical Research Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60506
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61606
Country
United States
Facility Name
Indiana University Health Bloomington Hospital
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47402
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Oschner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
VA Medical Center/University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Shady Grove Medical Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Saint Joseph Mercy Health System / Michigan Heart
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
29216
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Lester E. Cox Health Systems
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
AtlantiCare Regional Medical Center
City
Pomona
State/Province
New Jersey
ZIP/Postal Code
08240
Country
United States
Facility Name
Montefore Medical Center - Albert Einstein University Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Presbyterian/Brooklyn Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
University of North Carolina School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke (Duke Heart Center)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Novant Health Matthews Medical Center
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28240
Country
United States
Facility Name
New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Good Samaritan Hospital
City
Ephrata
State/Province
Pennsylvania
ZIP/Postal Code
17522
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Main Line Health System
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Greenville Hospital System University Medical Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Black Hills Cardiovascular Research
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah Hospitals and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Inova Health Care Services
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Virginia Commonwealth University Health
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35181553
Citation
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.
Results Reference
derived
PubMed Identifier
33714745
Citation
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.
Results Reference
derived
Links:
URL
http://dcri.org
Description
Related Info

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

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