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

Heart Failure Clinical Trial

— TRANSFORM-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03296813
• Other study ID #: Pro00080595
• Secondary ID: U01HL125511-01A1
• Status: Completed
• Phase: Phase 3
• Start date: July 11, 2018
• Est. completion date: July 29, 2022

Study information

• Verified date: January 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2859
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Torsemide
Loop diuretic
• Furosemide
Loop diuretic

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Russel Medical Center	Alexander City	Alabama
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Emory Health Care	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	Fox Valley Clinical Research Center	Aurora	Illinois
United States	VA Medical Center/University of Maryland	Baltimore	Maryland
United States	Indiana University Health Bloomington Hospital	Bloomington	Indiana
United States	Montefore Medical Center - Albert Einstein University Hospital	Bronx	New York
United States	Presbyterian/Brooklyn Methodist Hospital	Brooklyn	New York
United States	University of North Carolina School of Medicine	Chapel Hill	North Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke (Duke Heart Center)	Durham	North Carolina
United States	Good Samaritan Hospital	Ephrata	Pennsylvania
United States	Inova Health Care Services	Falls Church	Virginia
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	University of Florida - Gainesville	Gainesville	Florida
United States	Greenville Hospital System University Medical Center	Greenville	South Carolina
United States	Saint Francis Hospital and Medical Center	Hartford	Connecticut
United States	Queens Medical Center	Honolulu	Hawaii
United States	The Heart Center, PC	Huntsville	Alabama
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	V.A. Greater Los Angeles Healthcare System	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	Novant Health Matthews Medical Center	Matthews	North Carolina
United States	Loyola University Medical Center	Maywood	Illinois
United States	Froedtert Hospital	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Intermountain Medical Center	Murray	Utah
United States	Yale	New Haven	Connecticut
United States	Oschner Clinic	New Orleans	Louisiana
United States	University Medical Center	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Jefferson University Hospital	Philadelphia	Pennsylvania
United States	AtlantiCare Regional Medical Center	Pomona	New Jersey
United States	Black Hills Cardiovascular Research	Rapid City	South Dakota
United States	Virginia Commonwealth University Health	Richmond	Virginia
United States	Shady Grove Medical Center	Rockville	Maryland
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Utah Hospitals and Clinics	Salt Lake City	Utah
United States	Kaiser Permanente Medical Center	San Francisco	California
United States	Lester E. Cox Health Systems	Springfield	Missouri
United States	Stony Brook University Hospital	Stony Brook	New York
United States	University of Arizona	Tucson	Arizona
United States	West Haven VA Medical Center	West Haven	Connecticut
United States	New Hanover Regional Medical Center	Wilmington	North Carolina
United States	Main Line Health System	Wynnewood	Pennsylvania
United States	Saint Joseph Mercy Health System / Michigan Heart	Ypsilanti	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI), Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality, as measured by follow-up phone call	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.	30 months
Secondary	All-cause mortality or all-cause hospitalization, as measured by follow-up phone call	All-cause mortality or all-cause hospitalization over 12 months	12 months
Secondary	Total hospitalizations, as measured by follow-up phone call	Total hospitalizations over 12 months	12 months
Secondary	All-cause mortality or all-cause hospitalization, as measured by follow-up phone call	All-cause mortality or all-cause hospitalization over 30 days	30 days
Secondary	Health-related quality of life, as measured by follow-up phone call	Health-related quality of life over 12 months	12 months
Secondary	Symptoms of depression, as measured by follow-up phone call	Symptoms of depression over 12 months	12 months

External Links

•   Related Info
•   TRANSFORM-HF study website