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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03057977




Registration number
NCT03057977
Ethics application status
Date submitted
16/02/2017
Date registered
20/02/2017
Date last updated
18/05/2021

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
Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
Timepoint [1] 0 0
From randomisation until completion of the planned treatment period, up to 1040 days.
Secondary outcome [1] 0 0
Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)
Timepoint [1] 0 0
From randomisation until completion of the planned treatment phase, up to 1040 days.
Secondary outcome [2] 0 0
eGFR (CKD-EPI) cr Slope of Change From Baseline
Timepoint [2] 0 0
Assessed at baseline, week 4, 12, 32, 52, 76, 100, 124, 148 and at end of treatment (EOT), up to 1040 days.
Secondary outcome [3] 0 0
Time to First Event in Composite Renal Endpoint: Chronic Dialysis, Renal Transplant or Sustained Reduction of eGFR(CKD-EPI)cr
Timepoint [3] 0 0
From randomisation until completion of the planned treatment period, up to 1040 days.
Secondary outcome [4] 0 0
Time to First Adjudicated Hospitalisation for Heart Failure (HHF)
Timepoint [4] 0 0
From randomisation until completion of the planned treatment period, up to 1040 days.
Secondary outcome [5] 0 0
Time to Adjudicated Cardiovascular (CV) Death
Timepoint [5] 0 0
From randomisation until completion of the planned treatment period, up to 1040 days.
Secondary outcome [6] 0 0
Time to All-cause Mortality
Timepoint [6] 0 0
From randomisation until completion of the planned treatment period, up to 1040 days.
Secondary outcome [7] 0 0
Time to Onset of Diabetes Mellitus (DM)
Timepoint [7] 0 0
From randomisation until completion of the planned treatment period, up to 1040 days.
Secondary outcome [8] 0 0
Change From Baseline in KCCQ (Kansas City Cardiomyopathy Questionnaire) Clinical Summary Score at Week 52
Timepoint [8] 0 0
Assessed at baseline, week 12, week 32 and week 52.
Secondary outcome [9] 0 0
Number of All-cause Hospitalizations (First and Recurrent)
Timepoint [9] 0 0
From randomisation until completion of the planned treatment phase, up to 1040 days.

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/05/2020
Sample size
Target
Accrual to date
Final
3730
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
CORE Research Group - Milton
Recruitment hospital [3] 0 0
Mater Hospital Brisbane - South Brisbane
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
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
4064 - Milton
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5035 - Ashford
Recruitment postcode(s) [5] 0 0
5063 - Fullarton
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3076 - Epping
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3065 - Fitzroy
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3220 - Geelong
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment outside Australia
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Japan
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Japan
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Japan
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Swansea

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/ct2/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