EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)

Completed · Phase 3 · Has a placebo group

Conditions studied: Heart Failure

In brief

The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.

Key facts

Study ID

NCT03057977

Run by

Boehringer Ingelheim

People needed

3730

Starts

2017-03-06

Expected to finish

2020-05-28

Last updated by the study team

2021-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
• Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
• If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
• If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
• If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
• EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
• Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
• Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
• Signed and dated written ICF (Informed Consent Form)
• Further inclusion criteria apply

You may not qualify if…

• Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
• Heart transplant recipient, or listed for heart transplant
• Acute decompensated HF
• Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
• Symptomatic hypotension and/or a SBP < 100 mmHg
• Indication of liver disease
• Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
• History of ketoacidosis
• Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
• Currently enrolled in another investigational device or drug study
• Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial
• Further exclusion criteria apply

Where it is running

• Long Beach Center for Clinical Research — Long Beach, California, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• Merced Vein and Vascular Center — Merced, California, United States
• University of California Irvine — Orange, California, United States
• Covigilant Research, LLC — Riverside, California, United States
• University of California — Torrance, California, United States
• Orange County Research Center — Tustin, California, United States
• Blue Coast Cardiology — Vista, California, United States
• South Denver Cardiology Associates, PC — Littleton, Colorado, United States
• Integrated Heart Care — Boca Raton, Florida, United States
• Morton Plant Mease Health Care — Clearwater, Florida, United States
• Nature Coast Clinical Research — Crystal River, Florida, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Integrative Research Associates — Fort Lauderdale, Florida, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• East Coast Institute for Research, LLC — Jacksonville, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Cardiovascular Research Center of South Florida — Miami, Florida, United States
• Peninsula Research, Inc. — Ormond Beach, Florida, United States
• Cardiology Consultants, Inc — Pensacola, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Grady Clinical Research Center — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• La Mesa Cardiac Center — La Mesa, California, United States

Full record on ClinicalTrials.gov

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