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.
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.
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
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There are 60 Locations for this study
Alexander City Alabama, 35010, United States
Huntsville Alabama, 35801, United States
Tucson Arizona, 85724, United States
Los Angeles California, 90073, United States
San Francisco California, 94115, United States
Hartford Connecticut, 06105, United States
New Haven Connecticut, 06511, United States
West Haven Connecticut, 06516, United States
Fort Lauderdale Florida, 33308, United States
Gainesville Florida, 32610, United States
Atlanta Georgia, 30322, United States
Augusta Georgia, 30912, United States
Honolulu Hawaii, 96813, United States
Aurora Illinois, 60506, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Maywood Illinois, 60153, United States
Peoria Illinois, 61606, United States
Bloomington Indiana, 47402, United States
Indianapolis Indiana, 46202, United States
Iowa City Iowa, 52242, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21201, United States
Rockville Maryland, 20850, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48202, United States
Ypsilanti Michigan, 48197, United States
Minneapolis Minnesota, 55455, United States
Jackson Mississippi, 29216, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65807, United States
Pomona New Jersey, 08240, United States
Bronx New York, 10461, United States
Brooklyn New York, 11215, United States
Manhasset New York, 11030, United States
New York New York, 10021, United States
New York New York, 10029, United States
New York New York, 10032, United States
Stony Brook New York, 11794, United States
Chapel Hill North Carolina, 27514, United States
Durham North Carolina, 27710, United States
Matthews North Carolina, 28240, United States
Wilmington North Carolina, 28401, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Abington Pennsylvania, 19001, United States
Ephrata Pennsylvania, 17522, United States
Philadelphia Pennsylvania, 19102, United States
Philadelphia Pennsylvania, 19107, United States
Wynnewood Pennsylvania, 19096, United States
Greenville South Carolina, 29605, United States
Rapid City South Dakota, 57701, United States
Dallas Texas, 75246, United States
Murray Utah, 84107, United States
Salt Lake City Utah, 84132, United States
Falls Church Virginia, 22042, United States
Norfolk Virginia, 23507, United States
Richmond Virginia, 23298, United States
Milwaukee Wisconsin, 53226, United States
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