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

Phase 3

Completed

• Conditions: Heart Failure
• Interventions: Drug: Torsemide; Drug: Furosemide

• Registration Number: NCT03296813
• Lead Sponsor: Duke University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-28
• Study Start: 2018-07-11
• Status Verified: 2022-01
• Primary Completion: 2022-07-29
• Study Completion: 2022-07-29
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2859

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Torsemide	Torsemide	Oral dosing of torsemide compared to furosemide will be 1mg:2-4mg.
Furosemide	Furosemide	Oral dosing of torsemide compared to furosemide will be 1mg:2-4mg. For patients receiving loop diuretics other than furosemide, conversion to furosemide equivalents will be as follows: 1 mg oral torsemide = 2-4 mg oral furosemide 1 mg oral or intravenous bumetanide = 40 mg oral furosemide

Primary Outcome Measures

Name	Time	Method
All-cause mortality, as measured by follow-up phone call	30 months	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.

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life, as measured by follow-up phone call	12 months	Health-related quality of life over 12 months
Total hospitalizations, as measured by follow-up phone call	12 months	Total hospitalizations over 12 months
Symptoms of depression, as measured by follow-up phone call	12 months	Symptoms of depression over 12 months
All-cause mortality or all-cause hospitalization, as measured by follow-up phone call	30 days	All-cause mortality or all-cause hospitalization over 30 days

Trial Locations

Locations (60)

Russel Medical Center; 🇺🇸 Alexander City, Alabama, United States

The Heart Center, PC; 🇺🇸 Huntsville, Alabama, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

V.A. Greater Los Angeles Healthcare System; 🇺🇸 Los Angeles, California, United States

Kaiser Permanente Medical Center; 🇺🇸 San Francisco, California, United States

Saint Francis Hospital and Medical Center; 🇺🇸 Hartford, Connecticut, United States

Yale; 🇺🇸 New Haven, Connecticut, United States

West Haven VA Medical Center; 🇺🇸 West Haven, Connecticut, United States

Holy Cross Hospital; 🇺🇸 Fort Lauderdale, Florida, United States

University of Florida - Gainesville; 🇺🇸 Gainesville, Florida, United States

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