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

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ClinicalTrials.gov Identifier: NCT03296813
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : February 20, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Yale University
Information provided by (Responsible Party):
Duke University

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
Heart Failure Drug: Torsemide Drug: Furosemide 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : August 14, 2022
Estimated Study Completion Date : August 14, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. All-cause mortality, as measured by follow-up phone call [ Time Frame: 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 [ Time Frame: 12 months ]
    All-cause mortality or all-cause hospitalization over 12 months

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

  3. All-cause mortality or all-cause hospitalization, as measured by follow-up phone call [ Time Frame: 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 [ Time Frame: 12 months ]
    Health-related quality of life over 12 months

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296813


Contacts
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Contact: Shelby Morgan 336-816-5266 shelby.morgan@duke.edu
Contact: Sharon Settles 919-406-4805 sharon.settles@duke.edu

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Locations
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United States, Alabama
Russel Medical Center Recruiting
Alexander City, Alabama, United States, 35010
Principal Investigator: William Davis         
The Heart Center, PC Recruiting
Huntsville, Alabama, United States, 35801
Principal Investigator: Walter H Haught         
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Principal Investigator: Sophia Airhart         
United States, Connecticut
Yale Recruiting
New Haven, Connecticut, United States, 06511
Principal Investigator: Jeff Testani         
United States, Florida
Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
Principal Investigator: Joshua Larned         
United States, Georgia
Emory Health Care Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Robert Cole         
United States, Hawaii
Queens Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Principal Investigator: Todd Seto         
United States, Illinois
Fox Valley Clinical Research Center Recruiting
Aurora, Illinois, United States, 60506
Principal Investigator: Basharat Muneer         
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Jonathan Rich         
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Nir Uriel         
UnityPoint Health Cardiovascular Services Recruiting
Peoria, Illinois, United States, 61606
Principal Investigator: Alexander Adler         
United States, Indiana
Indiana University Medical Center Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Peter Pang         
United States, Louisiana
University Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Principal Investigator: Frank Smart         
Oschner Clinic Recruiting
New Orleans, Louisiana, United States, 70121
Principal Investigator: Hector Ventura         
United States, Maryland
VA Medical Center/University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Stephen Gottlieb         
Shady Grove Medical Center Recruiting
Rockville, Maryland, United States, 20850
Principal Investigator: Geetha Pinto         
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Scott Hummel         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Gillian Grafton         
Saint Joseph Mercy Health System / Michigan Heart Recruiting
Ypsilanti, Michigan, United States, 48197
Principal Investigator: Ahmad MizYed         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 29216
Principal Investigator: Michael Hall         
United States, Missouri
Truman Medical Center Withdrawn
Kansas City, Missouri, United States, 64108
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Justin Vader         
Lester E. Cox Health Systems Recruiting
Springfield, Missouri, United States, 65807
Principal Investigator: Justice Arhinful         
United States, New Jersey
AtlantiCare Regional Medical Center Recruiting
Pomona, New Jersey, United States, 08240
Principal Investigator: Sanjay Shetty         
United States, New York
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Principal Investigator: Gerin Stevens         
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Principal Investigator: Parag Goyal         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Arthur Garan         
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Principal Investigator: Hal Skopicki         
United States, North Carolina
Duke (Duke Heart Center) Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Tracy DeWald         
Novant Health Matthews Medical Center Recruiting
Matthews, North Carolina, United States, 28240
Principal Investigator: Lokesh Tejwani         
New Hanover Regional Medical Center Recruiting
Wilmington, North Carolina, United States, 28401
Principal Investigator: John Rommel         
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Principal Investigator: Mahazarin Ginwalla         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Wilson Tang         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Principal Investigator: Donald Haas         
Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Gordon Reeves         
United States, South Dakota
Black Hills Cardiovascular Research Recruiting
Rapid City, South Dakota, United States, 57701
Principal Investigator: Michael D'Urso         
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Principal Investigator: Melody Sherwood         
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Principal Investigator: Michael McCulloch         
University of Utah Hospitals and Clinics Recruiting
Salt Lake City, Utah, United States, 84132
Principal Investigator: James Fang         
United States, Virginia
Inova Health Care Services Recruiting
Falls Church, Virginia, United States, 22042
Principal Investigator: Mitchell Psotka         
Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Yale University
Investigators
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Principal Investigator: Eric Velazquez, MD Yale University
Principal Investigator: Robert Mentz, MD Duke University

Additional Information:
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03296813     History of Changes
Other Study ID Numbers: Pro00080595
U01HL125511-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Furosemide
Diuretics
Torsemide
Sodium Potassium Chloride Symporter Inhibitors
Natriuretic Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents