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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Heart Failure

Treatments: Drug: Empagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03057977

1245.121

2016-002280-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 3,730 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,730 participants in 2 patient groups, including a placebo group

Empagliflozin

Experimental group

Treatment:

Drug: Empagliflozin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo