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
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9500 Euclid Avenue
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
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4725 North Federal Highway
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(954) 771-8000
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2500 N State St
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300 Community Drive
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(516) 562-0100
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North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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1200 Old York Road
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
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2799 W Grand Blvd
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Huntsville, Alabama 35801
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545 Barnhill Dr
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2301 Holmes
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660 S Euclid Ave
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