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

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT03296813
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), Yale University (Other)
2,859
Enrollment
60
Locations
2
Arms
48.6
Actual Duration (Months)
47.7
Patients Per Site
1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2859 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure
Actual Study Start Date :
Jul 11, 2018
Actual Primary Completion Date :
Jul 29, 2022
Actual Study Completion Date :
Jul 29, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Torsemide

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

Drug: Torsemide
Loop diuretic
Active Comparator: 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

Drug: Furosemide
Loop diuretic

Outcome Measures

Primary Outcome Measures

  1. All-cause mortality, as measured by follow-up phone call [30 months]

    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

  1. All-cause mortality or all-cause hospitalization, as measured by follow-up phone call [12 months]

    All-cause mortality or all-cause hospitalization over 12 months

  2. Total hospitalizations, as measured by follow-up phone call [12 months]

    Total hospitalizations over 12 months

  3. All-cause mortality or all-cause hospitalization, as measured by follow-up phone call [30 days]

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

  4. Health-related quality of life, as measured by follow-up phone call [12 months]

    Health-related quality of life over 12 months

  5. Symptoms of depression, as measured by follow-up phone call [12 months]

    Symptoms of depression over 12 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  2. 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)

  3. 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)

  4. Plan for a daily outpatient oral loop diuretic regimen upon hospital discharge with anticipated need for long-term loop diuretic use

  5. ≥ 18 years of age

  6. 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

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 Kaiser Permanente Medical Center San Francisco California United States 94115
6 Saint Francis Hospital and Medical Center Hartford Connecticut United States 06105
7 Yale New Haven Connecticut United States 06511
8 West Haven VA Medical Center West Haven Connecticut United States 06516
9 Holy Cross Hospital Fort Lauderdale Florida United States 33308
10 University of Florida - Gainesville Gainesville Florida United States 32610
11 Emory Health Care Atlanta Georgia United States 30322
12 Augusta University Augusta Georgia United States 30912
13 Queens Medical Center Honolulu Hawaii United States 96813
14 Fox Valley Clinical Research Center Aurora Illinois United States 60506
15 Northwestern Memorial Hospital Chicago Illinois United States 60611
16 University of Chicago Chicago Illinois United States 60637
17 Loyola University Medical Center Maywood Illinois United States 60153
18 Methodist Medical Center of Illinois Peoria Illinois United States 61606
19 Indiana University Health Bloomington Hospital Bloomington Indiana United States 47402
20 Indiana University Medical Center Indianapolis Indiana United States 46202
21 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
22 University Medical Center New Orleans Louisiana United States 70112
23 Oschner Clinic New Orleans Louisiana United States 70121
24 VA Medical Center/University of Maryland Baltimore Maryland United States 21201
25 Shady Grove Medical Center Rockville Maryland United States 20850
26 University of Michigan Medical Center Ann Arbor Michigan United States 48109
27 Henry Ford Hospital Detroit Michigan United States 48202
28 Saint Joseph Mercy Health System / Michigan Heart Ypsilanti Michigan United States 48197
29 University of Minnesota Minneapolis Minnesota United States 55455
30 University of Mississippi Medical Center Jackson Mississippi United States 29216
31 Washington University School of Medicine Saint Louis Missouri United States 63110
32 Lester E. Cox Health Systems Springfield Missouri United States 65807
33 AtlantiCare Regional Medical Center Pomona New Jersey United States 08240
34 Montefore Medical Center - Albert Einstein University Hospital Bronx New York United States 10461
35 Presbyterian/Brooklyn Methodist Hospital Brooklyn New York United States 11215
36 North Shore University Hospital Manhasset New York United States 11030
37 Weill Cornell Medical College New York New York United States 10021
38 Mount Sinai New York New York United States 10029-6574
39 Columbia University Medical Center New York New York United States 10032
40 Stony Brook University Hospital Stony Brook New York United States 11794
41 University of North Carolina School of Medicine Chapel Hill North Carolina United States 27514
42 Duke (Duke Heart Center) Durham North Carolina United States 27710
43 Novant Health Matthews Medical Center Matthews North Carolina United States 28240
44 New Hanover Regional Medical Center Wilmington North Carolina United States 28401
45 University Hospitals Case Medical Center Cleveland Ohio United States 44106
46 Cleveland Clinic Cleveland Ohio United States 44195
47 Abington Memorial Hospital Abington Pennsylvania United States 19001
48 Good Samaritan Hospital Ephrata Pennsylvania United States 17522
49 Drexel University College of Medicine Philadelphia Pennsylvania United States 19102
50 Jefferson University Hospital Philadelphia Pennsylvania United States 19107
51 Main Line Health System Wynnewood Pennsylvania United States 19096
52 Greenville Hospital System University Medical Center Greenville South Carolina United States 29605
53 Black Hills Cardiovascular Research Rapid City South Dakota United States 57701
54 Baylor University Medical Center Dallas Texas United States 75246
55 Intermountain Medical Center Murray Utah United States 84107
56 University of Utah Hospitals and Clinics Salt Lake City Utah United States 84132
57 Inova Health Care Services Falls Church Virginia United States 22042
58 Sentara Norfolk General Hospital Norfolk Virginia United States 23507
59 Virginia Commonwealth University Health Richmond Virginia United States 23298
60 Froedtert Hospital Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • Duke University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Yale University

Investigators

  • Principal Investigator: Eric Velazquez, MD, Yale University
  • Principal Investigator: Robert Mentz, MD, Duke University

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03296813
Other Study ID Numbers:
  • Pro00080595
  • U01HL125511-01A1
First Posted:
Sep 28, 2017
Last Update Posted:
Aug 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Duke University
loop diuretic
Additional relevant MeSH terms:
Heart Failure
Torsemide
Furosemide

Study Results

No Results Posted as of Aug 19, 2022