Heart Failure Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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 is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

2859

Study ID:

NCT03296813

Recruitment Status:

Completed

Sponsor:

Duke University

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There are 60 Locations for this study

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Russel Medical Center
Alexander City Alabama, 35010, United States
The Heart Center, PC
Huntsville Alabama, 35801, United States
University of Arizona
Tucson Arizona, 85724, United States
V.A. Greater Los Angeles Healthcare System
Los Angeles California, 90073, United States
Kaiser Permanente Medical Center
San Francisco California, 94115, United States
Saint Francis Hospital and Medical Center
Hartford Connecticut, 06105, United States
Yale
New Haven Connecticut, 06511, United States
West Haven VA Medical Center
West Haven Connecticut, 06516, United States
Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
University of Florida - Gainesville
Gainesville Florida, 32610, United States
Emory Health Care
Atlanta Georgia, 30322, United States
Augusta University
Augusta Georgia, 30912, United States
Queens Medical Center
Honolulu Hawaii, 96813, United States
Fox Valley Clinical Research Center
Aurora Illinois, 60506, United States
Northwestern Memorial Hospital
Chicago Illinois, 60611, United States
University of Chicago
Chicago Illinois, 60637, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61606, United States
Indiana University Health Bloomington Hospital
Bloomington Indiana, 47402, United States
Indiana University Medical Center
Indianapolis Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
University Medical Center
New Orleans Louisiana, 70112, United States
Oschner Clinic
New Orleans Louisiana, 70121, United States
VA Medical Center/University of Maryland
Baltimore Maryland, 21201, United States
Shady Grove Medical Center
Rockville Maryland, 20850, United States
University of Michigan Medical Center
Ann Arbor Michigan, 48109, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Saint Joseph Mercy Health System / Michigan Heart
Ypsilanti Michigan, 48197, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
University of Mississippi Medical Center
Jackson Mississippi, 29216, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Lester E. Cox Health Systems
Springfield Missouri, 65807, United States
AtlantiCare Regional Medical Center
Pomona New Jersey, 08240, United States
Montefore Medical Center - Albert Einstein University Hospital
Bronx New York, 10461, United States
Presbyterian/Brooklyn Methodist Hospital
Brooklyn New York, 11215, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Weill Cornell Medical College
New York New York, 10021, United States
Mount Sinai
New York New York, 10029, United States
Columbia University Medical Center
New York New York, 10032, United States
Stony Brook University Hospital
Stony Brook New York, 11794, United States
University of North Carolina School of Medicine
Chapel Hill North Carolina, 27514, United States
Duke (Duke Heart Center)
Durham North Carolina, 27710, United States
Novant Health Matthews Medical Center
Matthews North Carolina, 28240, United States
New Hanover Regional Medical Center
Wilmington North Carolina, 28401, United States
University Hospitals Case Medical Center
Cleveland Ohio, 44106, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Good Samaritan Hospital
Ephrata Pennsylvania, 17522, United States
Drexel University College of Medicine
Philadelphia Pennsylvania, 19102, United States
Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
Main Line Health System
Wynnewood Pennsylvania, 19096, United States
Greenville Hospital System University Medical Center
Greenville South Carolina, 29605, United States
Black Hills Cardiovascular Research
Rapid City South Dakota, 57701, United States
Baylor University Medical Center
Dallas Texas, 75246, United States
Intermountain Medical Center
Murray Utah, 84107, United States
University of Utah Hospitals and Clinics
Salt Lake City Utah, 84132, United States
Inova Health Care Services
Falls Church Virginia, 22042, United States
Sentara Norfolk General Hospital
Norfolk Virginia, 23507, United States
Virginia Commonwealth University Health
Richmond Virginia, 23298, United States
Froedtert Hospital
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

2859

Study ID:

NCT03296813

Recruitment Status:

Completed

Sponsor:


Duke University

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