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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03057977




Registration number
NCT03057977
Ethics application status
Date submitted
16/02/2017
Date registered
20/02/2017
Date last updated
19/06/2020

Titles & IDs
Public title
EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)
Scientific 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)
Secondary ID [1] 0 0
2016-002280-34
Secondary ID [2] 0 0
1245.121
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Empagliflozin
Treatment: Drugs - Placebo

Experimental: Empagliflozin -

Placebo Comparator: Placebo -


Treatment: Drugs: Empagliflozin
once daily

Treatment: Drugs: Placebo
once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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) - 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)
Timepoint [1] 0 0
up to 38 months
Secondary outcome [1] 0 0
Occurrence of adjudicated HHF (Hospitalisation for Heart Failure) (first and recurrent) - Occurrence of adjudicated HHF (Hospitalisation for Heart Failure) (first and recurrent)
Timepoint [1] 0 0
up to 38 months
Secondary outcome [2] 0 0
eGFR (Estimated Glomerular Filtration Rate) (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation))cr slope of change from baseline - eGFR (Estimated Glomerular Filtration Rate) (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation))cr slope of change from baseline
Timepoint [2] 0 0
up to 38 months
Secondary outcome [3] 0 0
Time to first occurrence of chronic dialysis or renal transplant or sustained reduction of eGFR - 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
Timepoint [3] 0 0
up to 38 months
Secondary outcome [4] 0 0
Time to first adjudicated HHF (Hospitalisation for Heart Failure) - Time to first adjudicated HHF (Hospitalisation for Heart Failure)
Timepoint [4] 0 0
up to 38 months
Secondary outcome [5] 0 0
Time to adjudicated CV (Cardiovascular) death - Time to adjudicated CV (Cardiovascular) death
Timepoint [5] 0 0
up to 38 months
Secondary outcome [6] 0 0
Time to all-cause mortality - Time to all-cause mortality
Timepoint [6] 0 0
up to 38 months
Secondary outcome [7] 0 0
Time to onset of DM (Diabetes Mellitus) - Time to onset of DM (Diabetes Mellitus)
Timepoint [7] 0 0
up to 38 months
Secondary outcome [8] 0 0
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 - 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
Timepoint [8] 0 0
Baseline and Week 52
Secondary outcome [9] 0 0
Occurrence of all-cause hospitalisation (first and recurrent) - Occurrence of all-cause hospitalisation (first and recurrent)
Timepoint [9] 0 0
up to 38 months

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Mater Hospital Brisbane - Brisbane
Recruitment hospital [3] 0 0
CORE Research Group - Milton
Recruitment hospital [4] 0 0
SA-Heart Ashford Specialist Centre - Ashford
Recruitment hospital [5] 0 0
Heart and Vascular Research - Fullarton
Recruitment hospital [6] 0 0
The Northern Hospital - Epping
Recruitment hospital [7] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [8] 0 0
University Hospital Geelong - Geelong
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Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
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4101 - Brisbane
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4064 - Milton
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5035 - Ashford
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5063 - Fullarton
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3076 - Epping
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3065 - Fitzroy
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3220 - Geelong
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3050 - Parkville
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03057977
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications