Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03057977
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057977
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : October 16, 2019
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE February 16, 2017
First Posted Date  ICMJE February 20, 2017
Last Update Posted Date October 16, 2019
Actual Study Start Date  ICMJE March 6, 2017
Estimated Primary Completion Date June 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
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 ]
Change History Complete list of historical versions of study NCT03057977 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
  • 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)
  • 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
  • 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
  • Time to first adjudicated HHF (Hospitalisation for Heart Failure) [ Time Frame: up to 38 months ]
    Time to first adjudicated HHF (Hospitalisation for Heart Failure)
  • Time to adjudicated CV (Cardiovascular) death [ Time Frame: up to 38 months ]
    Time to adjudicated CV (Cardiovascular) death
  • Time to all-cause mortality [ Time Frame: up to 38 months ]
    Time to all-cause mortality
  • Time to onset of DM (Diabetes Mellitus) [ Time Frame: up to 38 months ]
    Time to onset of DM (Diabetes Mellitus)
  • 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
  • Occurrence of all-cause hospitalisation (first and recurrent) [ Time Frame: up to 38 months ]
    Occurrence of all-cause hospitalisation (first and recurrent)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
  • Occurrence of adjudicated HHF (Hospitalisation for Heart Failure) (first and recurrent) [ 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 [ Time Frame: up to 38 months ]
  • Time to first occurrence of sustained reduction of eGFR [ Time Frame: up to 38 months ]
    Time to first occurrence of 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
  • Time to first adjudicated HHF (Hospitalisation for Heart Failure) [ Time Frame: up to 38 months ]
  • Time to adjudicated CV (Cardiovascular) death [ Time Frame: up to 38 months ]
  • Time to all-cause mortality [ Time Frame: up to 38 months ]
  • Time to onset of DM (Diabetes Mellitus) [ Time Frame: up to 38 months ]
  • 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 ]
  • Occurrence of all-cause hospitalisation (first and recurrent) [ Time Frame: up to 38 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Drug: Empagliflozin
    once daily
    Other Name: JARDIANCE, JARDIANZ, GIBTULIO
  • Drug: Placebo
    once daily
Study Arms  ICMJE
  • Experimental: Empagliflozin
    Intervention: Drug: Empagliflozin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
3600
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2017)
2850
Estimated Study Completion Date  ICMJE July 20, 2020
Estimated Primary Completion Date June 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   China,   Czechia,   France,   Germany,   Hungary,   India,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03057977
Other Study ID Numbers  ICMJE 1245.121
2016-002280-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP