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

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ClinicalTrials.gov Identifier: NCT03057977
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : December 11, 2019
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Empagliflozin Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : June 19, 2020
Estimated Study Completion Date : July 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Empagliflozin Drug: Empagliflozin
once daily
Other Name: JARDIANCE, JARDIANZ, GIBTULIO
Placebo Comparator: Placebo Drug: Placebo
once daily


Outcome Measures
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Primary Outcome Measures :
  1. Composite primary endpoint - Time to first event of adjudicated CV (Cardiovascular) death or adjudicated HHF (Hospitalisation for Heart Failure) in patients with Heart Failure with reduced Ejection Fraction (HFrEF) [ Time Frame: up to 38 months ]
    Composite primary endpoint - Time to first event of adjudicated CV (Cardiovascular) death or adjudicated HHF (Hospitalisation for Heart Failure) in patients with Heart Failure with reduced Ejection Fraction (HFrEF)


Secondary Outcome Measures :
  1. Occurrence of adjudicated HHF (Hospitalisation for Heart Failure) (first and recurrent) [ Time Frame: up to 38 months ]
    Occurrence of adjudicated HHF (Hospitalisation for Heart Failure) (first and recurrent)

  2. eGFR (Estimated Glomerular Filtration Rate) (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation))cr slope of change from baseline [ Time Frame: up to 38 months ]
    eGFR (Estimated Glomerular Filtration Rate) (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation))cr slope of change from baseline

  3. Time to first occurrence of chronic dialysis or renal transplant or sustained reduction of eGFR [ Time Frame: up to 38 months ]

    Time to first occurrence of chronic dialysis or renal transplant or sustained reduction of >= 40% eGFR (CKD-EPI)cr or

    • sustained eGFR (CKD-EPI)cr <15 mL/min/1.73 m2 for patients with baseline eGFR >=30 mL/min/1.73 m2
    • sustained eGFR (CKD-EPI)cr <10 mL/min/1.73 m2 for patients with baseline eGFR <30 mL/min/1.73 m2

  4. Time to first adjudicated HHF (Hospitalisation for Heart Failure) [ Time Frame: up to 38 months ]
    Time to first adjudicated HHF (Hospitalisation for Heart Failure)

  5. Time to adjudicated CV (Cardiovascular) death [ Time Frame: up to 38 months ]
    Time to adjudicated CV (Cardiovascular) death

  6. Time to all-cause mortality [ Time Frame: up to 38 months ]
    Time to all-cause mortality

  7. Time to onset of DM (Diabetes Mellitus) [ Time Frame: up to 38 months ]
    Time to onset of DM (Diabetes Mellitus)

  8. Change from baseline in clinical summary score (HF (Chronic Heart Failure) symptoms and physical limitations domains) of the Kansas City Cardiomyopathy Questionnaire (KCCQ) at week 52 [ Time Frame: Baseline and Week 52 ]
    Change from baseline in clinical summary score (HF (Chronic Heart Failure) symptoms and physical limitations domains) of the Kansas City Cardiomyopathy Questionnaire (KCCQ) at week 52

  9. Occurrence of all-cause hospitalisation (first and recurrent) [ Time Frame: up to 38 months ]
    Occurrence of all-cause hospitalisation (first and recurrent)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057977


Contacts
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Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

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Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03057977     History of Changes
Other Study ID Numbers: 1245.121
2016-002280-34 ( EudraCT Number )
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Empagliflozin
 Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs