TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure
- Registration Number
- NCT03296813
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2859
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Torsemide Torsemide Oral dosing of torsemide compared to furosemide will be 1mg:2-4mg. Furosemide 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method Health-related quality of life, as measured by follow-up phone call 12 months Health-related quality of life over 12 months
Total hospitalizations, as measured by follow-up phone call 12 months Total hospitalizations over 12 months
Symptoms of depression, as measured by follow-up phone call 12 months Symptoms of depression over 12 months
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
Trial Locations
- Locations (60)
Weill Cornell Medical College
🇺🇸New York, New York, United States
VA Medical Center/University of Maryland
🇺🇸Baltimore, Maryland, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Emory Health Care
🇺🇸Atlanta, Georgia, United States
University of Florida - Gainesville
🇺🇸Gainesville, Florida, United States
Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Fox Valley Clinical Research Center
🇺🇸Aurora, Illinois, United States
Mount Sinai
🇺🇸New York, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Indiana University Health Bloomington Hospital
🇺🇸Bloomington, Indiana, United States
University of North Carolina School of Medicine
🇺🇸Chapel Hill, North Carolina, United States
Duke (Duke Heart Center)
🇺🇸Durham, North Carolina, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Novant Health Matthews Medical Center
🇺🇸Matthews, North Carolina, United States
Black Hills Cardiovascular Research
🇺🇸Rapid City, South Dakota, United States
Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Inova Health Care Services
🇺🇸Falls Church, Virginia, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
The Heart Center, PC
🇺🇸Huntsville, Alabama, United States
Russel Medical Center
🇺🇸Alexander City, Alabama, United States
West Haven VA Medical Center
🇺🇸West Haven, Connecticut, United States
V.A. Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
Yale
🇺🇸New Haven, Connecticut, United States
Queens Medical Center
🇺🇸Honolulu, Hawaii, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Oschner Clinic
🇺🇸New Orleans, Louisiana, United States
University Medical Center
🇺🇸New Orleans, Louisiana, United States
Shady Grove Medical Center
🇺🇸Rockville, Maryland, United States
Saint Joseph Mercy Health System / Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
AtlantiCare Regional Medical Center
🇺🇸Pomona, New Jersey, United States
Presbyterian/Brooklyn Methodist Hospital
🇺🇸Brooklyn, New York, United States
Montefore Medical Center - Albert Einstein University Hospital
🇺🇸Bronx, New York, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Main Line Health System
🇺🇸Wynnewood, Pennsylvania, United States
Virginia Commonwealth University Health
🇺🇸Richmond, Virginia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Lester E. Cox Health Systems
🇺🇸Springfield, Missouri, United States
Greenville Hospital System University Medical Center
🇺🇸Greenville, South Carolina, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Good Samaritan Hospital
🇺🇸Ephrata, Pennsylvania, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Kaiser Permanente Medical Center
🇺🇸San Francisco, California, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Utah Hospitals and Clinics
🇺🇸Salt Lake City, Utah, United States
Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States