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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

Tracking Information
First Submitted Date  ICMJE September 26, 2017
First Posted Date  ICMJE September 28, 2017
Last Update Posted Date February 20, 2019
Actual Study Start Date  ICMJE July 11, 2018
Estimated Primary Completion Date August 14, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2017)
All-cause mortality, as measured by follow-up phone call [ Time Frame: 12 months ]
All-cause mortality over a follow-up period of 12 months
Change History Complete list of historical versions of study NCT03296813 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
  • 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
  • Total hospitalizations, as measured by follow-up phone call [ Time Frame: 12 months ]
    Total hospitalizations over 12 months
  • 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
  • Health-related quality of life, as measured by follow-up phone call [ Time Frame: 12 months ]
    Health-related quality of life over 12 months
  • Symptoms of depression, as measured by follow-up phone call [ Time Frame: 12 months ]
    Symptoms of depression over 12 months
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2017)
  • All-cause hospitalization, as measured by follow-up phone call [ Time Frame: 12 months ]
    All-cause hospitalization over 12 months
  • Total hospitalizations, as measured by follow-up phone call [ Time Frame: 12 months ]
    Total hospitalizations over 12 months
  • 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
  • Health-related quality of life, as measured by follow-up phone call [ Time Frame: 12 months ]
    Health-related quality of life over 12 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure
Official Title  ICMJE TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Drug: Torsemide
    Loop diuretic
  • Drug: Furosemide
    Loop diuretic
Study Arms  ICMJE
  • Active Comparator: Torsemide
    Oral dosing of torsemide compared to furosemide will be 1mg:2-4mg.
    Intervention: Drug: Torsemide
  • 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

    Intervention: Drug: Furosemide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2017)
6000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 14, 2022
Estimated Primary Completion Date August 14, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shelby Morgan 336-816-5266 shelby.morgan@duke.edu
Contact: Sharon Settles 919-406-4805 sharon.settles@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03296813
Other Study ID Numbers  ICMJE Pro00080595
U01HL125511-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Yale University
Investigators  ICMJE
Principal Investigator: Eric Velazquez, MD Yale University
Principal Investigator: Robert Mentz, MD Duke University
PRS Account Duke University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP