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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:July 11, 2018
End Date:August 14, 2022
Contact:Shelby Morgan
Email:shelby.morgan@duke.edu
Phone:336-816-5266

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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.

- 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.

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
We found this trial at
40
sites
1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Principal Investigator: Todd Seto
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Nir Uriel
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Wilson Tang
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Principal Investigator: Melody Sherwood
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Principal Investigator: Joshua Larned
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Michael Hall
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
Principal Investigator: Gerin Stevens
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Manhasset, NY
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Principal Investigator: Donald Haas
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Alexander City, Alabama 35010
Principal Investigator: William Davis
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Ann Arbor, Michigan 48109
Principal Investigator: Scott Hummel
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Atlanta, Georgia 30303
Principal Investigator: Robert Cole
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Aurora, Illinois 60504
Principal Investigator: Basharat Muneer
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Baltimore, Maryland 21201
Principal Investigator: Stephen Gottlieb
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Jonathan Rich
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Cleveland, Ohio 44194
Principal Investigator: Mahazarin Ginwalla
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Gillian Grafton
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Durham, North Carolina 27710
Principal Investigator: Tracy DeWald
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Falls Church, Virginia 22042
Principal Investigator: Mitchell Psotka
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Huntsville, Alabama 35801
Principal Investigator: Walter H Haught
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545 Barnhill Dr
Indianapolis, Indiana 46201
(317) 274-8157
Principal Investigator: Peter Pang
Indiana University Medical Center Indiana University Health is Indiana
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2301 Holmes
Kansas City, Missouri 64108
816-404-1000
Principal Investigator: Daniel Pauly
Truman Medical Center Located in the heart of downtown Kansas City, TMC Hospital Hill is...
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Matthews, North Carolina 28105
Principal Investigator: Lokesh Tejwani
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Principal Investigator: Michael McCulloch
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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New Haven, Connecticut 06520
Principal Investigator: Jeff Testani
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New Orleans, Louisiana 70112
Principal Investigator: Frank Smart
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New Orleans, Louisiana 70121
Principal Investigator: Hector Ventura
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New York, New York 10021
Principal Investigator: Parag Goyal
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Arthur Garan
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Peoria, Illinois 61606
Principal Investigator: Alexander Adler
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Philadelphia, Pennsylvania 19107
Principal Investigator: Gordon Reeves
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Pomona, New Jersey 08240
Principal Investigator: Sanjay Shetty
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Rapid City, South Dakota 57701
Principal Investigator: Michael D'Urso
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Rockville, Maryland 20850
Principal Investigator: Geetha Pinto
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Justin Vader
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Salt Lake City, Utah 84132
Principal Investigator: James Fang
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Springfield, Missouri 65807
Principal Investigator: Justice Arhinful
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Stony Brook, New York 11794
Principal Investigator: Hal Skopicki
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Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Sophia Airhart
University of Arizona The University of Arizona is a premier, public research university. Established in...
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Wilmington, North Carolina 28401
Principal Investigator: John Rommel
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Ypsilanti, Michigan 48197
Principal Investigator: Ahmad MizYed
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