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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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)
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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)
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Secondary ID [1]
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0
2016-002280-34
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Secondary ID [2]
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1245.121
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Condition category
Condition code
Cardiovascular
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0
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Coronary heart disease
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Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
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Assessment method [1]
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Time to the first event of adjudicated cardiovascular (CV) death or adjudicated hospitalisation for heart failure (HHF). The incidence rate per 100 patient years (100 \* number of patients with event /time at risk \[years\]) is presented. With time at risk \[year\] calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.
Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.
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Timepoint [1]
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From randomisation until completion of the planned treatment period, up to 1040 days.
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Secondary outcome [1]
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Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)
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Assessment method [1]
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Reported is the total number of HHF events (first and recurrent) which occurred.
All data up to the end of the planned treatment period (including the data after the end of treatment for patients not completing the treatment period as planned) from all randomised patients was used.
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Timepoint [1]
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From randomisation until completion of the planned treatment phase, up to 1040 days.
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Secondary outcome [2]
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eGFR (CKD-EPI) cr Slope of Change From Baseline
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Assessment method [2]
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Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) \[mL/min/1.73m2\] slope of change from baseline.
Available on-treatment change-from-baseline data were to be used. Patients without on-treatment data after randomisation were not to be included in this analysis. Slope represents the long term effect on eGFR.
Timepoints after baseline were included in calculation of slope of change from baseline. Descriptive statistic (mean(standard error)) is reported.
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Timepoint [2]
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Assessed at baseline, week 4, 12, 32, 52, 76, 100, 124, 148 and at end of treatment (EOT), up to 1040 days.
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Secondary outcome [3]
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Time to First Event in Composite Renal Endpoint: Chronic Dialysis, Renal Transplant or Sustained Reduction of eGFR(CKD-EPI)cr
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Assessment method [3]
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Time to the first event in the composite renal endpoint: chronic dialysis (with a frequency of twice per week or more for at least 90 days), renal transplant, or sustained reduction in Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr).
The incidence rate per 100 patient years (100 \* number of patients with event /time at risk \[years\]) is presented. With time at risk \[year\] calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.
Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.
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Timepoint [3]
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From randomisation until completion of the planned treatment period, up to 1040 days.
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Secondary outcome [4]
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Time to First Adjudicated Hospitalisation for Heart Failure (HHF)
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Assessment method [4]
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Time to first adjudicated Hospitalisation for Heart Failure (HHF). The incidence rate per 100 patient years (100 \* number of patients with event /time at risk \[years\]) is presented. With time at risk \[year\] calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25. Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.
Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.
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Timepoint [4]
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From randomisation until completion of the planned treatment period, up to 1040 days.
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Secondary outcome [5]
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Time to Adjudicated Cardiovascular (CV) Death
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Assessment method [5]
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Time to adjudicated CV (Cardiovascular) death. The incidence rate (patients with events per 100 person years at risk) is reported.
The incidence rate per 100 patient years (100 \* number of patients with event /time at risk \[years\]) is presented. With time at risk \[year\] calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.
Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.
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Timepoint [5]
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From randomisation until completion of the planned treatment period, up to 1040 days.
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Secondary outcome [6]
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Time to All-cause Mortality
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Assessment method [6]
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Time to all-cause mortality. The incidence rate (patients with events per 100 person years at risk) is reported.
The incidence rate per 100 patient years (100 \* number of patients with event /time at risk \[years\]) is presented. With time at risk \[year\] calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.
Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.
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Timepoint [6]
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From randomisation until completion of the planned treatment period, up to 1040 days.
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Secondary outcome [7]
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Time to Onset of Diabetes Mellitus (DM)
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Assessment method [7]
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Time to onset of DM (Glycated haemoglobin (HbA1c) =6.5% or as diagnosed by the investigator) in patients with pre-DM (no history of DM and no HbA1c =6.5% before treatment, and a pre-treatment HbA1c value of 5.7 to \<6.5%). The incidence rate (patients with events per 100 person years at risk) is reported.
The incidence rate per 100 patient years (100 \* number of patients with event /time at risk \[years\]) is presented. With time at risk \[year\] calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.
Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.
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Timepoint [7]
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From randomisation until completion of the planned treatment period, up to 1040 days.
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Secondary outcome [8]
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Change From Baseline in KCCQ (Kansas City Cardiomyopathy Questionnaire) Clinical Summary Score at Week 52
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Assessment method [8]
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Change from baseline in KCCQ (Kansas City cardiomyopathy questionnaire) clinical summary score at Week 52. The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, selfefficacy, and quality of life in patients with Heart Failure. The KCCQ-clinical summary score comprises the following domains: Symptom frequency, symptom burden and physical limitation. The score is calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.
For patients who died, a worst score (score of 0) is imputed at all subsequent scheduled visits after the date of death.
Standard error is adjusted standard error. Change from baseline in KCCQ-score at week 52 was modeled using a MMRM with visit (week 12, 32 and 52) as repeated measures, adjusted mean (standard error) at week 52 is reported.
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Timepoint [8]
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Assessed at baseline, week 12, week 32 and week 52.
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Secondary outcome [9]
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Number of All-cause Hospitalizations (First and Recurrent)
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Assessment method [9]
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Number of all-cause hospitalizations (first and recurrent).
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Timepoint [9]
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From randomisation until completion of the planned treatment phase, up to 1040 days.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/03/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/05/2020
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Sample size
Target
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Accrual to date
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Final
3730
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [2]
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CORE Research Group - Milton
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Recruitment hospital [3]
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Mater Hospital Brisbane - South Brisbane
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Recruitment hospital [4]
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SA-Heart Ashford Specialist Centre - Ashford
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Recruitment hospital [5]
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Heart and Vascular Research - Fullarton
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Recruitment hospital [6]
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The Northern Hospital - Epping
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Recruitment hospital [7]
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St Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [8]
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University Hospital Geelong - Geelong
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Recruitment hospital [9]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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2305 - New Lambton Heights
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Recruitment postcode(s) [2]
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4064 - Milton
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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5035 - Ashford
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Recruitment postcode(s) [5]
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5063 - Fullarton
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Recruitment postcode(s) [6]
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3076 - Epping
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Recruitment postcode(s) [7]
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3065 - Fitzroy
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Recruitment postcode(s) [8]
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3220 - Geelong
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Recruitment postcode(s) [9]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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Colorado
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Bahia Blanca
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Caba
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Argentina
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Ciudadela
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Coronel Suarez
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Mechelen
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Brazil
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Belo Horizonte
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Brazil
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Campinas
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Fortaleza
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Brazil
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Goiania
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Brazil
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Goiânia
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Brazil
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Marília
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Brazil
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Recife
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Brazil
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Ribeirão Preto
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Brazil
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Rio De Janeiro - RJ
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Brazil
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Rio de Janeiro
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Brazil
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Santo André
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Brazil
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Sao Jose do Rio Preto
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Country [79]
0
0
Brazil
Query!
State/province [79]
0
0
Sao Paulo
Query!
Country [80]
0
0
Brazil
Query!
State/province [80]
0
0
São Bernardo do Campo
Query!
Country [81]
0
0
Brazil
Query!
State/province [81]
0
0
São Paulo
Query!
Country [82]
0
0
Brazil
Query!
State/province [82]
0
0
Vitória
Query!
Country [83]
0
0
Brazil
Query!
State/province [83]
0
0
Votuporanga
Query!
Country [84]
0
0
Canada
Query!
State/province [84]
0
0
Alberta
Query!
Country [85]
0
0
Canada
Query!
State/province [85]
0
0
British Columbia
Query!
Country [86]
0
0
Canada
Query!
State/province [86]
0
0
Manitoba
Query!
Country [87]
0
0
Canada
Query!
State/province [87]
0
0
New Brunswick
Query!
Country [88]
0
0
Canada
Query!
State/province [88]
0
0
Nova Scotia
Query!
Country [89]
0
0
Canada
Query!
State/province [89]
0
0
Ontario
Query!
Country [90]
0
0
Canada
Query!
State/province [90]
0
0
Quebec
Query!
Country [91]
0
0
China
Query!
State/province [91]
0
0
Beijing
Query!
Country [92]
0
0
China
Query!
State/province [92]
0
0
Changchun
Query!
Country [93]
0
0
China
Query!
State/province [93]
0
0
Changsha
Query!
Country [94]
0
0
China
Query!
State/province [94]
0
0
Dongguan
Query!
Country [95]
0
0
China
Query!
State/province [95]
0
0
Fuzhou
Query!
Country [96]
0
0
China
Query!
State/province [96]
0
0
Guangzhou
Query!
Country [97]
0
0
China
Query!
State/province [97]
0
0
Haikou
Query!
Country [98]
0
0
China
Query!
State/province [98]
0
0
Lanzhou
Query!
Country [99]
0
0
China
Query!
State/province [99]
0
0
Luzhou
Query!
Country [100]
0
0
China
Query!
State/province [100]
0
0
Nanchang
Query!
Country [101]
0
0
China
Query!
State/province [101]
0
0
Nanjing
Query!
Country [102]
0
0
China
Query!
State/province [102]
0
0
Shanghai
Query!
Country [103]
0
0
China
Query!
State/province [103]
0
0
Shenyang
Query!
Country [104]
0
0
China
Query!
State/province [104]
0
0
Tianjin
Query!
Country [105]
0
0
China
Query!
State/province [105]
0
0
Wuhan
Query!
Country [106]
0
0
China
Query!
State/province [106]
0
0
Xi'an
Query!
Country [107]
0
0
China
Query!
State/province [107]
0
0
Yanji
Query!
Country [108]
0
0
China
Query!
State/province [108]
0
0
Yueyang
Query!
Country [109]
0
0
China
Query!
State/province [109]
0
0
Zhenjiang
Query!
Country [110]
0
0
Czechia
Query!
State/province [110]
0
0
Bilovec
Query!
Country [111]
0
0
Czechia
Query!
State/province [111]
0
0
Brandys Nad
Query!
Country [112]
0
0
Czechia
Query!
State/province [112]
0
0
Brno
Query!
Country [113]
0
0
Czechia
Query!
State/province [113]
0
0
Broumov
Query!
Country [114]
0
0
Czechia
Query!
State/province [114]
0
0
Chrudim
Query!
Country [115]
0
0
Czechia
Query!
State/province [115]
0
0
Frydek-Mistek
Query!
Country [116]
0
0
Czechia
Query!
State/province [116]
0
0
Louny
Query!
Country [117]
0
0
Czechia
Query!
State/province [117]
0
0
Olomouc
Query!
Country [118]
0
0
Czechia
Query!
State/province [118]
0
0
Pardubice
Query!
Country [119]
0
0
Czechia
Query!
State/province [119]
0
0
Prag 5
Query!
Country [120]
0
0
Czechia
Query!
State/province [120]
0
0
Prague 2
Query!
Country [121]
0
0
Czechia
Query!
State/province [121]
0
0
Praha 4 - Krc
Query!
Country [122]
0
0
Czechia
Query!
State/province [122]
0
0
Prerov
Query!
Country [123]
0
0
Czechia
Query!
State/province [123]
0
0
Pribram
Query!
Country [124]
0
0
Czechia
Query!
State/province [124]
0
0
Trebic
Query!
Country [125]
0
0
Czechia
Query!
State/province [125]
0
0
Usti nad Labem
Query!
Country [126]
0
0
Czechia
Query!
State/province [126]
0
0
Zlin
Query!
Country [127]
0
0
Czechia
Query!
State/province [127]
0
0
Znojmo
Query!
Country [128]
0
0
France
Query!
State/province [128]
0
0
Bayonne
Query!
Country [129]
0
0
France
Query!
State/province [129]
0
0
Besançon
Query!
Country [130]
0
0
France
Query!
State/province [130]
0
0
Bron
Query!
Country [131]
0
0
France
Query!
State/province [131]
0
0
Caen
Query!
Country [132]
0
0
France
Query!
State/province [132]
0
0
Montpellier
Query!
Country [133]
0
0
France
Query!
State/province [133]
0
0
Paris
Query!
Country [134]
0
0
France
Query!
State/province [134]
0
0
Pau
Query!
Country [135]
0
0
France
Query!
State/province [135]
0
0
Pessac
Query!
Country [136]
0
0
France
Query!
State/province [136]
0
0
Toulouse
Query!
Country [137]
0
0
France
Query!
State/province [137]
0
0
Vandoeuvre-lès-Nancy
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Aachen
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Berlin
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Bielefeld
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Dessau-Roßlau
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Dortmund
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Dresden
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Erfurt
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Essen
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Frankfurt
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Göttingen
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Hamburg
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Hannover
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Heidelberg
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Homburg
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Jena
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Kiel
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Langen
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Lüdenscheid
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Lüneburg
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Mainz
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
München
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Nienburg
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Papenburg
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Regensburg
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Riesa
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Wangen
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Warendorf
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Wuppertal
Query!
Country [166]
0
0
Hungary
Query!
State/province [166]
0
0
Baja
Query!
Country [167]
0
0
Hungary
Query!
State/province [167]
0
0
Bekescsaba
Query!
Country [168]
0
0
Hungary
Query!
State/province [168]
0
0
Budapest
Query!
Country [169]
0
0
Hungary
Query!
State/province [169]
0
0
Debrecen
Query!
Country [170]
0
0
Hungary
Query!
State/province [170]
0
0
Gyongyos
Query!
Country [171]
0
0
Hungary
Query!
State/province [171]
0
0
Komarom
Query!
Country [172]
0
0
Hungary
Query!
State/province [172]
0
0
Nagykanizsa
Query!
Country [173]
0
0
Hungary
Query!
State/province [173]
0
0
Oroshaza
Query!
Country [174]
0
0
Hungary
Query!
State/province [174]
0
0
Pecs
Query!
Country [175]
0
0
Hungary
Query!
State/province [175]
0
0
Pécs
Query!
Country [176]
0
0
Hungary
Query!
State/province [176]
0
0
Szekesfehervar
Query!
Country [177]
0
0
Hungary
Query!
State/province [177]
0
0
Veszprem
Query!
Country [178]
0
0
India
Query!
State/province [178]
0
0
Ahmedabad
Query!
Country [179]
0
0
India
Query!
State/province [179]
0
0
Aurangabad
Query!
Country [180]
0
0
India
Query!
State/province [180]
0
0
Bangalore
Query!
Country [181]
0
0
India
Query!
State/province [181]
0
0
Bengaluru
Query!
Country [182]
0
0
India
Query!
State/province [182]
0
0
Chennai
Query!
Country [183]
0
0
India
Query!
State/province [183]
0
0
Gurgaon
Query!
Country [184]
0
0
India
Query!
State/province [184]
0
0
Kolkatta
Query!
Country [185]
0
0
India
Query!
State/province [185]
0
0
Nashik
Query!
Country [186]
0
0
India
Query!
State/province [186]
0
0
Nasik
Query!
Country [187]
0
0
India
Query!
State/province [187]
0
0
New Delhi
Query!
Country [188]
0
0
Italy
Query!
State/province [188]
0
0
Benevento
Query!
Country [189]
0
0
Italy
Query!
State/province [189]
0
0
Bergamo
Query!
Country [190]
0
0
Italy
Query!
State/province [190]
0
0
Cona (FE)
Query!
Country [191]
0
0
Italy
Query!
State/province [191]
0
0
Cortona (AR)
Query!
Country [192]
0
0
Italy
Query!
State/province [192]
0
0
Milano
Query!
Country [193]
0
0
Italy
Query!
State/province [193]
0
0
Napoli
Query!
Country [194]
0
0
Italy
Query!
State/province [194]
0
0
Pisa
Query!
Country [195]
0
0
Italy
Query!
State/province [195]
0
0
Roma
Query!
Country [196]
0
0
Italy
Query!
State/province [196]
0
0
Trieste
Query!
Country [197]
0
0
Japan
Query!
State/province [197]
0
0
Aichi, Kasugai
Query!
Country [198]
0
0
Japan
Query!
State/province [198]
0
0
Aichi, Nagoya
Query!
Country [199]
0
0
Japan
Query!
State/province [199]
0
0
Aichi, Toyota
Query!
Country [200]
0
0
Japan
Query!
State/province [200]
0
0
Chiba, Chiba
Query!
Country [201]
0
0
Japan
Query!
State/province [201]
0
0
Chiba, Kisarazu
Query!
Country [202]
0
0
Japan
Query!
State/province [202]
0
0
Chiba, Matsudo
Query!
Country [203]
0
0
Japan
Query!
State/province [203]
0
0
Ehime, Matsuyama
Query!
Country [204]
0
0
Japan
Query!
State/province [204]
0
0
Ehime, Uwajima
Query!
Country [205]
0
0
Japan
Query!
State/province [205]
0
0
Fukui, Fukui
Query!
Country [206]
0
0
Japan
Query!
State/province [206]
0
0
Fukuoka, Chikushino
Query!
Country [207]
0
0
Japan
Query!
State/province [207]
0
0
Fukuoka, Fukuoka
Query!
Country [208]
0
0
Japan
Query!
State/province [208]
0
0
Fukuoka, Iizuka
Query!
Country [209]
0
0
Japan
Query!
State/province [209]
0
0
Fukuoka, Kitakyushu
Query!
Country [210]
0
0
Japan
Query!
State/province [210]
0
0
Gifu, Ogaki
Query!
Country [211]
0
0
Japan
Query!
State/province [211]
0
0
Gifu, Seki
Query!
Country [212]
0
0
Japan
Query!
State/province [212]
0
0
Hiroshima, Fukuyama
Query!
Country [213]
0
0
Japan
Query!
State/province [213]
0
0
Hiroshima, Hatsukaichi
Query!
Country [214]
0
0
Japan
Query!
State/province [214]
0
0
Hiroshima, Shobara
Query!
Country [215]
0
0
Japan
Query!
State/province [215]
0
0
Hokkaido, Hakodate
Query!
Country [216]
0
0
Japan
Query!
State/province [216]
0
0
Hokkaido, Sapporo
Query!
Country [217]
0
0
Japan
Query!
State/province [217]
0
0
Hokkaido, Tomakomai
Query!
Country [218]
0
0
Japan
Query!
State/province [218]
0
0
Hyogo, Amagasaki
Query!
Country [219]
0
0
Japan
Query!
State/province [219]
0
0
Hyogo, Himeji
Query!
Country [220]
0
0
Japan
Query!
State/province [220]
0
0
Hyogo, Kobe
Query!
Country [221]
0
0
Japan
Query!
State/province [221]
0
0
Ibaraki, Higashiibaraki-gun
Query!
Country [222]
0
0
Japan
Query!
State/province [222]
0
0
Ishikawa, Kanazawa
Query!
Country [223]
0
0
Japan
Query!
State/province [223]
0
0
Kagawa, Kanonji
Query!
Country [224]
0
0
Japan
Query!
State/province [224]
0
0
Kagawa, Takamatsu
Query!
Country [225]
0
0
Japan
Query!
State/province [225]
0
0
Kanagawa, Sagamihara
Query!
Country [226]
0
0
Japan
Query!
State/province [226]
0
0
Kanagawa, Yokohama
Query!
Country [227]
0
0
Japan
Query!
State/province [227]
0
0
Kumamoto, Kumamoto
Query!
Country [228]
0
0
Japan
Query!
State/province [228]
0
0
Kumamoto, Yatsushiro
Query!
Country [229]
0
0
Japan
Query!
State/province [229]
0
0
Kyoto, Uji
Query!
Country [230]
0
0
Japan
Query!
State/province [230]
0
0
Miyagi, Sendai
Query!
Country [231]
0
0
Japan
Query!
State/province [231]
0
0
Miyazaki, Miyazaki
Query!
Country [232]
0
0
Japan
Query!
State/province [232]
0
0
Nagano, Nakano
Query!
Country [233]
0
0
Japan
Query!
State/province [233]
0
0
Nagasaki, Omura
Query!
Country [234]
0
0
Japan
Query!
State/province [234]
0
0
Okayama, Okayama
Query!
Country [235]
0
0
Japan
Query!
State/province [235]
0
0
Okinawa, Naha
Query!
Country [236]
0
0
Japan
Query!
State/province [236]
0
0
Okinawa, Shimajiri-gun
Query!
Country [237]
0
0
Japan
Query!
State/province [237]
0
0
Okinawa, Urasoe
Query!
Country [238]
0
0
Japan
Query!
State/province [238]
0
0
Osaka, Higashiosaka
Query!
Country [239]
0
0
Japan
Query!
State/province [239]
0
0
Osaka, Osaka
Query!
Country [240]
0
0
Japan
Query!
State/province [240]
0
0
Osaka, Sakai
Query!
Country [241]
0
0
Japan
Query!
State/province [241]
0
0
Osaka, Takatsuki
Query!
Country [242]
0
0
Japan
Query!
State/province [242]
0
0
Saitama, Saitama
Query!
Country [243]
0
0
Japan
Query!
State/province [243]
0
0
Shiga, Kusatsu
Query!
Country [244]
0
0
Japan
Query!
State/province [244]
0
0
Tokushima, Tokushima
Query!
Country [245]
0
0
Japan
Query!
State/province [245]
0
0
Tokyo, Meguro-ku
Query!
Country [246]
0
0
Japan
Query!
State/province [246]
0
0
Tokyo, Ome
Query!
Country [247]
0
0
Japan
Query!
State/province [247]
0
0
Tokyo, Ota-ku
Query!
Country [248]
0
0
Japan
Query!
State/province [248]
0
0
Tokyo, Toshima-ku
Query!
Country [249]
0
0
Japan
Query!
State/province [249]
0
0
Wakayama, Tanabe
Query!
Country [250]
0
0
Japan
Query!
State/province [250]
0
0
Yamaguchi, Shimonoseki
Query!
Country [251]
0
0
Korea, Republic of
Query!
State/province [251]
0
0
Busan
Query!
Country [252]
0
0
Korea, Republic of
Query!
State/province [252]
0
0
Cheongju
Query!
Country [253]
0
0
Korea, Republic of
Query!
State/province [253]
0
0
Daejeon
Query!
Country [254]
0
0
Korea, Republic of
Query!
State/province [254]
0
0
Incheon
Query!
Country [255]
0
0
Korea, Republic of
Query!
State/province [255]
0
0
Seoul
Query!
Country [256]
0
0
Korea, Republic of
Query!
State/province [256]
0
0
Sungnam
Query!
Country [257]
0
0
Korea, Republic of
Query!
State/province [257]
0
0
Wonju
Query!
Country [258]
0
0
Mexico
Query!
State/province [258]
0
0
Aguascalientes
Query!
Country [259]
0
0
Mexico
Query!
State/province [259]
0
0
Ciudad de Mexico
Query!
Country [260]
0
0
Mexico
Query!
State/province [260]
0
0
Distrito Federal
Query!
Country [261]
0
0
Mexico
Query!
State/province [261]
0
0
Guadalajara
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Funding & Sponsors
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Name
Boehringer Ingelheim
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Eli Lilly and Company
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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.
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Trial website
https://clinicaltrials.gov/study/NCT03057977
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Trial related presentations / publications
Ferreira JP, Zannad F, Butler J, Filippatos G, Pocock SJ, Brueckmann M, Steubl D, Schueler E, Anker SD, Packer M. Association of Empagliflozin Treatment With Albuminuria Levels in Patients With Heart Failure: A Secondary Analysis of EMPEROR-Pooled. JAMA Cardiol. 2022 Nov 1;7(11):1148-1159. doi: 10.1001/jamacardio.2022.2924. Erratum In: JAMA Cardiol. 2022 Nov 1;7(11):1177. doi: 10.1001/jamacardio.2022.4032. Ferreira JP, Zannad F, Butler J, Filipattos G, Ritter I, Schuler E, Kraus BJ, Pocock SJ, Anker SD, Packer M. Empagliflozin and serum potassium in heart failure: an analysis from EMPEROR-Pooled. Eur Heart J. 2022 Aug 14;43(31):2984-2993. doi: 10.1093/eurheartj/ehac306. Erratum In: Eur Heart J. 2022 Nov 1;43(41):4377. doi: 10.1093/eurheartj/ehac428. Ferreira JP, Butler J, Zannad F, Filippatos G, Schueler E, Steubl D, Zeller C, Januzzi JL, Pocock S, Packer M, Anker SD. Mineralocorticoid Receptor Antagonists and Empagliflozin in Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2022 Mar 29;79(12):1129-1137. doi: 10.1016/j.jacc.2022.01.029. Ferreira JP, Anker SD, Butler J, Filippatos G, Iwata T, Salsali A, Zeller C, Pocock SJ, Zannad F, Packer M. Impact of anaemia and the effect of empagliflozin in heart failure with reduced ejection fraction: findings from EMPEROR-Reduced. Eur J Heart Fail. 2022 Apr;24(4):708-715. doi: 10.1002/ejhf.2409. Epub 2022 Jan 9. Verma S, Dhingra NK, Butler J, Anker SD, Ferreira JP, Filippatos G, Januzzi JL, Lam CSP, Sattar N, Peil B, Nordaby M, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Reduced trial committees and investigators. Empagliflozin in the treatment of heart failure with reduced ejection fraction in addition to background therapies and therapeutic combinations (EMPEROR-Reduced): a post-hoc analysis of a randomised, double-blind trial. Lancet Diabetes Endocrinol. 2022 Jan;10(1):35-45. doi: 10.1016/S2213-8587(21)00292-8. Epub 2021 Nov 30. Ryden L, Ferrannini G. Is the impact of add on heart failure therapy influenced by background therapy? Lancet Diabetes Endocrinol. 2022 Jan;10(1):3-5. doi: 10.1016/S2213-8587(21)00311-9. Epub 2021 Nov 30. No abstract available. Bohm M, Anker SD, Butler J, Filippatos G, Ferreira JP, Pocock SJ, Mahfoud F, Brueckmann M, Jamal W, Ofstad AP, Schuler E, Ponikowski P, Wanner C, Zannad F, Packer M; EMPEROR-Reduced Trial Committees and Investigators. Empagliflozin Improves Cardiovascular and Renal Outcomes in Heart Failure Irrespective of Systolic Blood Pressure. J Am Coll Cardiol. 2021 Sep 28;78(13):1337-1348. doi: 10.1016/j.jacc.2021.07.049. Januzzi JL Jr, Zannad F, Anker SD, Butler J, Filippatos G, Pocock SJ, Ferreira JP, Sattar N, Verma S, Vedin O, Schnee J, Iwata T, Cotton D, Packer M; EMPEROR-Reduced Trial Committees and Investigators. Prognostic Importance of NT-proBNP and Effect of Empagliflozin in the EMPEROR-Reduced Trial. J Am Coll Cardiol. 2021 Sep 28;78(13):1321-1332. doi: 10.1016/j.jacc.2021.07.046. Packer M, Butler J, Zannad F, Filippatos G, Ferreira JP, Pocock SJ, Carson P, Anand I, Doehner W, Haass M, Komajda M, Miller A, Pehrson S, Teerlink JR, Schnaidt S, Zeller C, Schnee JM, Anker SD. Effect of Empagliflozin on Worsening Heart Failure Events in Patients With Heart Failure and Preserved Ejection Fraction: EMPEROR-Preserved Trial. Circulation. 2021 Oct 19;144(16):1284-1294. doi: 10.1161/CIRCULATIONAHA.121.056824. Epub 2021 Aug 29. Pocock SJ, Ferreira JP, Gregson J, Anker SD, Butler J, Filippatos G, Gollop ND, Iwata T, Brueckmann M, Januzzi JL, Voors AA, Zannad F, Packer M. Novel biomarker-driven prognostic models to predict morbidity and mortality in chronic heart failure: the EMPEROR-Reduced trial. Eur Heart J. 2021 Nov 14;42(43):4455-4464. doi: 10.1093/eurheartj/ehab579. Lam CSP, Ferreira JP, Pfarr E, Sim D, Tsutsui H, Anker SD, Butler J, Filippatos G, Pocock SJ, Sattar N, Verma S, Brueckmann M, Schnee J, Cotton D, Zannad F, Packer M. Regional and ethnic influences on the response to empagliflozin in patients with heart failure and a reduced ejection fraction: the EMPEROR-Reduced trial. Eur Heart J. 2021 Nov 14;42(43):4442-4451. doi: 10.1093/eurheartj/ehab360. Ferreira JP, Zannad F, Pocock SJ, Anker SD, Butler J, Filippatos G, Brueckmann M, Jamal W, Steubl D, Schueler E, Packer M. Interplay of Mineralocorticoid Receptor Antagonists and Empagliflozin in Heart Failure: EMPEROR-Reduced. J Am Coll Cardiol. 2021 Mar 23;77(11):1397-1407. doi: 10.1016/j.jacc.2021.01.044. Packer M, Anker SD, Butler J, Filippatos G, Ferreira JP, Pocock SJ, Sattar N, Brueckmann M, Jamal W, Cotton D, Iwata T, Zannad F; EMPEROR-Reduced Trial Committees and Investigators. Empagliflozin in Patients With Heart Failure, Reduced Ejection Fraction, and Volume Overload: EMPEROR-Reduced Trial. J Am Coll Cardiol. 2021 Mar 23;77(11):1381-1392. doi: 10.1016/j.jacc.2021.01.033. Butler J, Anker SD, Filippatos G, Khan MS, Ferreira JP, Pocock SJ, Giannetti N, Januzzi JL, Pina IL, Lam CSP, Ponikowski P, Sattar N, Verma S, Brueckmann M, Jamal W, Vedin O, Peil B, Zeller C, Zannad F, Packer M; EMPEROR-Reduced Trial Committees and Investigators. Empagliflozin and health-related quality of life outcomes in patients with heart failure with reduced ejection fraction: the EMPEROR-Reduced trial. Eur Heart J. 2021 Mar 31;42(13):1203-1212. doi: 10.1093/eurheartj/ehaa1007. Anker SD, Butler J, Filippatos G, Khan MS, Marx N, Lam CSP, Schnaidt S, Ofstad AP, Brueckmann M, Jamal W, Bocchi EA, Ponikowski P, Perrone SV, Januzzi JL, Verma S, Bohm M, Ferreira JP, Pocock SJ, Zannad F, Packer M. Effect of Empagliflozin on Cardiovascular and Renal Outcomes in Patients With Heart Failure by Baseline Diabetes Status: Results From the EMPEROR-Reduced Trial. Circulation. 2021 Jan 26;143(4):337-349. doi: 10.1161/CIRCULATIONAHA.120.051824. Epub 2020 Nov 11. Zannad F, Ferreira JP, Pocock SJ, Zeller C, Anker SD, Butler J, Filippatos G, Hauske SJ, Brueckmann M, Pfarr E, Schnee J, Wanner C, Packer M. Cardiac and Kidney Benefits of Empagliflozin in Heart Failure Across the Spectrum of Kidney Function: Insights From EMPEROR-Reduced. Circulation. 2021 Jan 26;143(4):310-321. doi: 10.1161/CIRCULATIONAHA.120.051685. Epub 2020 Oct 23. Erratum In: Circulation. 2021 Jan 26;143(4):e29. doi: 10.1161/CIR.0000000000000953. Packer M, Anker SD, Butler J, Filippatos G, Ferreira JP, Pocock SJ, Carson P, Anand I, Doehner W, Haass M, Komajda M, Miller A, Pehrson S, Teerlink JR, Brueckmann M, Jamal W, Zeller C, Schnaidt S, Zannad F. Effect of Empagliflozin on the Clinical Stability of Patients With Heart Failure and a Reduced Ejection Fraction: The EMPEROR-Reduced Trial. Circulation. 2021 Jan 26;143(4):326-336. doi: 10.1161/CIRCULATIONAHA.120.051783. Epub 2020 Oct 21. Erratum In: Circulation. 2021 Jan 26;143(4):e30. doi: 10.1161/CIR.0000000000000954. Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Bohm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28. Nassif ME, Kosiborod M. Effects of sodium glucose cotransporter type 2 inhibitors on heart failure. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:19-23. doi: 10.1111/dom.13678.
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Public notes
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Contacts
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Boehringer Ingelheim
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Boehringer Ingelheim
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/77/NCT03057977/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/77/NCT03057977/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03057977
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