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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03057951
Registration number
NCT03057951
Ethics application status
Date submitted
16/02/2017
Date registered
20/02/2017
Date last updated
6/06/2022
Titles & IDs
Public title
EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
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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 Preserved Ejection Fraction (HFpEF)
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Secondary ID [1]
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2016-002278-11
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Secondary ID [2]
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1245.110
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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: 10 mg 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 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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Failure with preserved Ejection Fraction (HFpEF). The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:
Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\].
Time at risk \[years\] = 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.
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Timepoint [1]
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From randomization until completion of the planned treatment phase, up to 1403 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 adjudicated HHF events (first and recurrent) which occurred.
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Timepoint [1]
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From randomization until completion of the planned treatment phase, up to 1403 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) slope of change from baseline.
Available on-treatment change-from-baseline data were used. The slope represents the long term effect of eGFR change from baseline and provides the yearly rate of decline.
Timepoints after baseline were included in calculation of slope of change from baseline.
The slope per patient was calculated using a random coefficient model with terms for treatment, region, baseline status of diabetes, age, sex, left ventricular ejection fraction (LVEF) and glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)cr) at baseline and in addition the factors "time", "treatment-by-time interaction", and "baseline eGFR (CKD-EPI)cr-by-time interaction".
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Timepoint [2]
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At baseline, week 4, 12, 32, 52, 76, 100, 124, 148, 172 and week 196, up to 1043 days.
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Secondary outcome [3]
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Time to the First Event in the Composite Renal Endpoint: Chronic Dialysis, Renal Transplant, or Sustained Reduction in eGFR (CKD-EPI)cr
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Assessment method [3]
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Chronic dialysis was defined as dialysis with a frequency of twice per week or more for at least 90 days.
Sustained was determined by two or more consecutive post-baseline central laboratory measurement separated by at least 30 days.
Reduction in glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) was defined as reduction in eGFR from baseline =40%, eGFR \<15 mL/min/1.73 m\^2 for patients with baseline eGFR =30 mL/min/1.73 m\^2, or eGFR \<10 mL/min/1.73 m\^2 for patients with baseline eGFR \<30 mL/min/1.73 m\^2.
The incidence rate per 100 patient years (100 \* number of patients with event / time at risk \[years\]) is reported. Time at risk \[year\] is calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Abbreviation:
Patient-years (pt-yrs).
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Timepoint [3]
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From randomization until completion of the planned treatment phase, up to 1403 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 HHF. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:
Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\].
Time at risk \[years\] = 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.
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Timepoint [4]
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0
From randomization until completion of the planned treatment phase, up to 1403 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 death. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:
Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\].
Time at risk \[years\] = 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.
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Timepoint [5]
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From randomization until completion of the planned treatment phase, up to 1403 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 per 100 patient years (pt-yrs) is presented and calculated as followed:
Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\].
Time at risk \[years\] = 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.
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Timepoint [6]
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From randomization until completion of the planned treatment phase, up to 1403 days.
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Secondary outcome [7]
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Time to Onset of Diabetes Mellitus (DM) in Patients With Pre-DM
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Assessment method [7]
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Time to onset of DM (defined as HbA1c =6.5% or as diagnosed by the investigator) in patients with pre-DM.
Pre-DM was defined as no history of DM and no HbA1c =6.5% before treatment, and a pre-treatment HbA1c value of =5.7% and \<6.5%.
The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:
Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\].
Time at risk \[years\] = 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.
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Timepoint [7]
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From randomization until completion of the planned treatment phase, to 1403 days.
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Secondary outcome [8]
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Change From Baseline in Kansas City Cardiomyopathy Questionaire (KCCQ) Clinical Summary Score at Week 52
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Assessment method [8]
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The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, self-efficacy, 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) was imputed for the score at all subsequent scheduled visits after the date of death where the score would have been assessed.
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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At baseline and at week 12, week 32 and week 52.
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Secondary outcome [9]
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Occurrence of All-cause Hospitalisation (First and Recurrent)
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Assessment method [9]
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Occurrence of all-cause hospitalisation (first and recurrent). Total number of all cause hospitalisations is reported.
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Timepoint [9]
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From randomization until completion of the planned treatment phase, up to 1403 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 preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
* Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1
* Stable dose of oral diuretics, if prescribed
* 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 (Heart Failure)
* 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))cr 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 trial
* 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 may 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
2/03/2017
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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
26/04/2021
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Sample size
Target
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Accrual to date
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Final
5988
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Pendlebury Research - Kotara
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Recruitment hospital [2]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [3]
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CORE Research Group - Milton
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Recruitment hospital [4]
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Gold Coast University Hospital - Southport
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Recruitment hospital [5]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [6]
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Adelaide Medical Research - Ashford
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Recruitment hospital [7]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [8]
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Heart and Vascular Research - Fullarton
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Recruitment hospital [9]
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The Queen Elizabeth Hospital - Woodville South
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Recruitment hospital [10]
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The Northern Hospital - Epping
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Recruitment hospital [11]
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Peninsula Private Hospital - Frankston
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Recruitment hospital [12]
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University Hospital Geelong - Geelong
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Recruitment hospital [13]
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Mount Hospital - Perth
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Recruitment postcode(s) [1]
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2289 - Kotara
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Recruitment postcode(s) [2]
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2305 - New Lambton Heights
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Recruitment postcode(s) [3]
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4064 - Milton
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Recruitment postcode(s) [4]
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4215 - Southport
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Recruitment postcode(s) [5]
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5000 - Adelaide
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Recruitment postcode(s) [6]
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5035 - Ashford
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Recruitment postcode(s) [7]
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5042 - Bedford Park
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Recruitment postcode(s) [8]
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5063 - Fullarton
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Recruitment postcode(s) [9]
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5011 - Woodville South
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Recruitment postcode(s) [10]
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3076 - Epping
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Recruitment postcode(s) [11]
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3199 - Frankston
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Recruitment postcode(s) [12]
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3220 - Geelong
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Recruitment postcode(s) [13]
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6000 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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Alabama
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California
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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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Iowa
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Kentucky
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Louisiana
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Maine
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Caba
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Coronel Suarez
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Quilmes
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Salta
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Santa Fé
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Vicente Lopez
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Villa Luro
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Liège
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Brazil
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Bela Vista
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Brazil
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Belo Horizonte
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Campina Grande do Sul
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Brazil
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Campinas
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Brazil
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Canoas
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Brazil
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Caxias do Sul
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Brazil
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Curitiba
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Marília
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Brazil
Query!
State/province [78]
0
0
Passo Fundo
Query!
Country [79]
0
0
Brazil
Query!
State/province [79]
0
0
Porto Alegre
Query!
Country [80]
0
0
Brazil
Query!
State/province [80]
0
0
Recife
Query!
Country [81]
0
0
Brazil
Query!
State/province [81]
0
0
Ribeirao Preto
Query!
Country [82]
0
0
Brazil
Query!
State/province [82]
0
0
Rio de Janeiro
Query!
Country [83]
0
0
Brazil
Query!
State/province [83]
0
0
Santa Efigenia
Query!
Country [84]
0
0
Brazil
Query!
State/province [84]
0
0
Santo André
Query!
Country [85]
0
0
Brazil
Query!
State/province [85]
0
0
Sao Jose do Rio Preto
Query!
Country [86]
0
0
Brazil
Query!
State/province [86]
0
0
Sao Paulo
Query!
Country [87]
0
0
Brazil
Query!
State/province [87]
0
0
São Bernardo do Campo
Query!
Country [88]
0
0
Brazil
Query!
State/province [88]
0
0
São Paulo
Query!
Country [89]
0
0
Brazil
Query!
State/province [89]
0
0
Vitória
Query!
Country [90]
0
0
Brazil
Query!
State/province [90]
0
0
Votuporanga
Query!
Country [91]
0
0
Canada
Query!
State/province [91]
0
0
Alberta
Query!
Country [92]
0
0
Canada
Query!
State/province [92]
0
0
British Columbia
Query!
Country [93]
0
0
Canada
Query!
State/province [93]
0
0
Manitoba
Query!
Country [94]
0
0
Canada
Query!
State/province [94]
0
0
New Brunswick
Query!
Country [95]
0
0
Canada
Query!
State/province [95]
0
0
Nova Scotia
Query!
Country [96]
0
0
Canada
Query!
State/province [96]
0
0
Ontario
Query!
Country [97]
0
0
Canada
Query!
State/province [97]
0
0
Quebec
Query!
Country [98]
0
0
Canada
Query!
State/province [98]
0
0
Saskatchewan
Query!
Country [99]
0
0
China
Query!
State/province [99]
0
0
Beijing
Query!
Country [100]
0
0
China
Query!
State/province [100]
0
0
Changchun
Query!
Country [101]
0
0
China
Query!
State/province [101]
0
0
Changsha
Query!
Country [102]
0
0
China
Query!
State/province [102]
0
0
Dongguan
Query!
Country [103]
0
0
China
Query!
State/province [103]
0
0
Fuzhou
Query!
Country [104]
0
0
China
Query!
State/province [104]
0
0
Guangzhou
Query!
Country [105]
0
0
China
Query!
State/province [105]
0
0
Haikou
Query!
Country [106]
0
0
China
Query!
State/province [106]
0
0
Lanzhou
Query!
Country [107]
0
0
China
Query!
State/province [107]
0
0
Luzhou
Query!
Country [108]
0
0
China
Query!
State/province [108]
0
0
Nanchang
Query!
Country [109]
0
0
China
Query!
State/province [109]
0
0
Nanjing
Query!
Country [110]
0
0
China
Query!
State/province [110]
0
0
Shanghai
Query!
Country [111]
0
0
China
Query!
State/province [111]
0
0
Shenyang
Query!
Country [112]
0
0
China
Query!
State/province [112]
0
0
Tianjin
Query!
Country [113]
0
0
China
Query!
State/province [113]
0
0
Wuhan
Query!
Country [114]
0
0
China
Query!
State/province [114]
0
0
Xi'an
Query!
Country [115]
0
0
China
Query!
State/province [115]
0
0
Yanji
Query!
Country [116]
0
0
China
Query!
State/province [116]
0
0
Yueyang
Query!
Country [117]
0
0
China
Query!
State/province [117]
0
0
Zhenjiang
Query!
Country [118]
0
0
Colombia
Query!
State/province [118]
0
0
Barranquilla
Query!
Country [119]
0
0
Colombia
Query!
State/province [119]
0
0
Bogota D.C
Query!
Country [120]
0
0
Colombia
Query!
State/province [120]
0
0
Bogota
Query!
Country [121]
0
0
Colombia
Query!
State/province [121]
0
0
Cali
Query!
Country [122]
0
0
Colombia
Query!
State/province [122]
0
0
Cartagena
Query!
Country [123]
0
0
Colombia
Query!
State/province [123]
0
0
Floridablanca
Query!
Country [124]
0
0
Colombia
Query!
State/province [124]
0
0
Manizales
Query!
Country [125]
0
0
Colombia
Query!
State/province [125]
0
0
Medellin
Query!
Country [126]
0
0
Czechia
Query!
State/province [126]
0
0
Bilovec
Query!
Country [127]
0
0
Czechia
Query!
State/province [127]
0
0
Brno
Query!
Country [128]
0
0
Czechia
Query!
State/province [128]
0
0
Broumov
Query!
Country [129]
0
0
Czechia
Query!
State/province [129]
0
0
Chrudim
Query!
Country [130]
0
0
Czechia
Query!
State/province [130]
0
0
Frydek-Mistek
Query!
Country [131]
0
0
Czechia
Query!
State/province [131]
0
0
Havlickuv Brod
Query!
Country [132]
0
0
Czechia
Query!
State/province [132]
0
0
Hradec Kralove
Query!
Country [133]
0
0
Czechia
Query!
State/province [133]
0
0
Louny
Query!
Country [134]
0
0
Czechia
Query!
State/province [134]
0
0
Marianske Lazne
Query!
Country [135]
0
0
Czechia
Query!
State/province [135]
0
0
Olomouc
Query!
Country [136]
0
0
Czechia
Query!
State/province [136]
0
0
Pardubice
Query!
Country [137]
0
0
Czechia
Query!
State/province [137]
0
0
Prague
Query!
Country [138]
0
0
Czechia
Query!
State/province [138]
0
0
Praha 2
Query!
Country [139]
0
0
Czechia
Query!
State/province [139]
0
0
Praha 4 - Krc
Query!
Country [140]
0
0
Czechia
Query!
State/province [140]
0
0
Praha 4
Query!
Country [141]
0
0
Czechia
Query!
State/province [141]
0
0
Praha 5
Query!
Country [142]
0
0
Czechia
Query!
State/province [142]
0
0
Prerov
Query!
Country [143]
0
0
Czechia
Query!
State/province [143]
0
0
Trebic
Query!
Country [144]
0
0
Czechia
Query!
State/province [144]
0
0
Tremosna
Query!
Country [145]
0
0
Czechia
Query!
State/province [145]
0
0
Trutnov
Query!
Country [146]
0
0
Czechia
Query!
State/province [146]
0
0
Uherske Hradiste
Query!
Country [147]
0
0
Czechia
Query!
State/province [147]
0
0
Unicov
Query!
Country [148]
0
0
Czechia
Query!
State/province [148]
0
0
Zlin
Query!
Country [149]
0
0
Czechia
Query!
State/province [149]
0
0
Znojmo
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Aachen
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Berlin
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Bielefeld
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Bochum
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Dessau-Roßlau
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Dortmund
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Dresden
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Erfurt
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Essen
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Frankfurt
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Göttingen
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Hannover
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Heidelberg
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Homburg
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Jena
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Kiel
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Langen
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Lüdenscheid
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Lüneburg
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Mainz
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Mannheim
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
München
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Nürnberg
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Papenburg
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Regensburg
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Riesa
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Wangen im Allgäu
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Warendorf
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Wermsdorf
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Wuppertal
Query!
Country [180]
0
0
Hungary
Query!
State/province [180]
0
0
Baja
Query!
Country [181]
0
0
Hungary
Query!
State/province [181]
0
0
Bekescsaba
Query!
Country [182]
0
0
Hungary
Query!
State/province [182]
0
0
Budapest
Query!
Country [183]
0
0
Hungary
Query!
State/province [183]
0
0
Debrecen
Query!
Country [184]
0
0
Hungary
Query!
State/province [184]
0
0
Gyongyos
Query!
Country [185]
0
0
Hungary
Query!
State/province [185]
0
0
Kalocsa
Query!
Country [186]
0
0
Hungary
Query!
State/province [186]
0
0
Komarom
Query!
Country [187]
0
0
Hungary
Query!
State/province [187]
0
0
Nagykanizsa
Query!
Country [188]
0
0
Hungary
Query!
State/province [188]
0
0
Nyiregyhaza
Query!
Country [189]
0
0
Hungary
Query!
State/province [189]
0
0
Oroshaza
Query!
Country [190]
0
0
Hungary
Query!
State/province [190]
0
0
Pecs
Query!
Country [191]
0
0
Hungary
Query!
State/province [191]
0
0
Szekesfehervar
Query!
Country [192]
0
0
Hungary
Query!
State/province [192]
0
0
Veszprem
Query!
Country [193]
0
0
India
Query!
State/province [193]
0
0
Ahmedabad
Query!
Country [194]
0
0
India
Query!
State/province [194]
0
0
Aurangabad
Query!
Country [195]
0
0
India
Query!
State/province [195]
0
0
Bangalore
Query!
Country [196]
0
0
India
Query!
State/province [196]
0
0
Bengaluru
Query!
Country [197]
0
0
India
Query!
State/province [197]
0
0
Chennai
Query!
Country [198]
0
0
India
Query!
State/province [198]
0
0
Gurgaon
Query!
Country [199]
0
0
India
Query!
State/province [199]
0
0
Guwahati
Query!
Country [200]
0
0
India
Query!
State/province [200]
0
0
Kolkatta
Query!
Country [201]
0
0
India
Query!
State/province [201]
0
0
Nashik
Query!
Country [202]
0
0
India
Query!
State/province [202]
0
0
Nasik
Query!
Country [203]
0
0
India
Query!
State/province [203]
0
0
New Delhi
Query!
Country [204]
0
0
Italy
Query!
State/province [204]
0
0
Benevento
Query!
Country [205]
0
0
Italy
Query!
State/province [205]
0
0
Bergamo
Query!
Country [206]
0
0
Italy
Query!
State/province [206]
0
0
Cona (FE)
Query!
Country [207]
0
0
Italy
Query!
State/province [207]
0
0
Cortona
Query!
Country [208]
0
0
Italy
Query!
State/province [208]
0
0
Milano
Query!
Country [209]
0
0
Italy
Query!
State/province [209]
0
0
Napoli
Query!
Country [210]
0
0
Italy
Query!
State/province [210]
0
0
Pisa
Query!
Country [211]
0
0
Italy
Query!
State/province [211]
0
0
Roma
Query!
Country [212]
0
0
Italy
Query!
State/province [212]
0
0
Rozzano (MI)
Query!
Country [213]
0
0
Italy
Query!
State/province [213]
0
0
Sesto San Giovanni (MI)
Query!
Country [214]
0
0
Italy
Query!
State/province [214]
0
0
Trieste
Query!
Country [215]
0
0
Japan
Query!
State/province [215]
0
0
Aichi, Kasugai
Query!
Country [216]
0
0
Japan
Query!
State/province [216]
0
0
Aichi, Nagoya
Query!
Country [217]
0
0
Japan
Query!
State/province [217]
0
0
Chiba, Chiba
Query!
Country [218]
0
0
Japan
Query!
State/province [218]
0
0
Chiba, Kisarazu
Query!
Country [219]
0
0
Japan
Query!
State/province [219]
0
0
Chiba, Matsudo
Query!
Country [220]
0
0
Japan
Query!
State/province [220]
0
0
Ehime, Matsuyama
Query!
Country [221]
0
0
Japan
Query!
State/province [221]
0
0
Ehime, Uwajima
Query!
Country [222]
0
0
Japan
Query!
State/province [222]
0
0
Fukui, Fukui
Query!
Country [223]
0
0
Japan
Query!
State/province [223]
0
0
Fukuoka, Chikushino
Query!
Country [224]
0
0
Japan
Query!
State/province [224]
0
0
Fukuoka, Fukuoka
Query!
Country [225]
0
0
Japan
Query!
State/province [225]
0
0
Fukuoka, Kitakyushu
Query!
Country [226]
0
0
Japan
Query!
State/province [226]
0
0
Fukushima, Shirakawa
Query!
Country [227]
0
0
Japan
Query!
State/province [227]
0
0
Gifu, Ogaki
Query!
Country [228]
0
0
Japan
Query!
State/province [228]
0
0
Gifu, Seki
Query!
Country [229]
0
0
Japan
Query!
State/province [229]
0
0
Hiroshima, Fukuyama
Query!
Country [230]
0
0
Japan
Query!
State/province [230]
0
0
Hiroshima, Shobara
Query!
Country [231]
0
0
Japan
Query!
State/province [231]
0
0
Hokkaido, Sapporo
Query!
Country [232]
0
0
Japan
Query!
State/province [232]
0
0
Hokkaido, Tomakomai
Query!
Country [233]
0
0
Japan
Query!
State/province [233]
0
0
Hokkaido,Otaru
Query!
Country [234]
0
0
Japan
Query!
State/province [234]
0
0
Hyogo, Amagasaki
Query!
Country [235]
0
0
Japan
Query!
State/province [235]
0
0
Hyogo, Himeji
Query!
Country [236]
0
0
Japan
Query!
State/province [236]
0
0
Hyogo, Kobe
Query!
Country [237]
0
0
Japan
Query!
State/province [237]
0
0
Ibaraki, Higashiibaraki-gun
Query!
Country [238]
0
0
Japan
Query!
State/province [238]
0
0
Ibaraki, Koga
Query!
Country [239]
0
0
Japan
Query!
State/province [239]
0
0
Ishikawa, Kanazawa
Query!
Country [240]
0
0
Japan
Query!
State/province [240]
0
0
Kagawa, Kanonji
Query!
Country [241]
0
0
Japan
Query!
State/province [241]
0
0
Kagawa, Takamatsu
Query!
Country [242]
0
0
Japan
Query!
State/province [242]
0
0
Kanagawa, Kawasaki
Query!
Country [243]
0
0
Japan
Query!
State/province [243]
0
0
Kanagawa, Sagamihara
Query!
Country [244]
0
0
Japan
Query!
State/province [244]
0
0
Kanagawa, Yokohama
Query!
Country [245]
0
0
Japan
Query!
State/province [245]
0
0
Kumamoto, Kumamoto
Query!
Country [246]
0
0
Japan
Query!
State/province [246]
0
0
Kumamoto, Yatsushiro
Query!
Country [247]
0
0
Japan
Query!
State/province [247]
0
0
Kusatsu
Query!
Country [248]
0
0
Japan
Query!
State/province [248]
0
0
Kyoto, Uji
Query!
Country [249]
0
0
Japan
Query!
State/province [249]
0
0
Miyagi, Sendai
Query!
Country [250]
0
0
Japan
Query!
State/province [250]
0
0
Miyazaki, Miyazaki
Query!
Country [251]
0
0
Japan
Query!
State/province [251]
0
0
Nagano, Nakano
Query!
Country [252]
0
0
Japan
Query!
State/province [252]
0
0
Nagasaki, Omura
Query!
Country [253]
0
0
Japan
Query!
State/province [253]
0
0
Oita, Oita
Query!
Country [254]
0
0
Japan
Query!
State/province [254]
0
0
Okayama, Okayama
Query!
Country [255]
0
0
Japan
Query!
State/province [255]
0
0
Okinawa, Naha
Query!
Country [256]
0
0
Japan
Query!
State/province [256]
0
0
Okinawa, Shimajiri-gun
Query!
Country [257]
0
0
Japan
Query!
State/province [257]
0
0
Okinawa, Urasoe
Query!
Country [258]
0
0
Japan
Query!
State/province [258]
0
0
Osaka, Higashiosaka
Query!
Country [259]
0
0
Japan
Query!
State/province [259]
0
0
Osaka, Osaka
Query!
Country [260]
0
0
Japan
Query!
State/province [260]
0
0
Osaka, Takatsuki
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Country [261]
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Funding & Sponsors
Primary sponsor type
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Name
Boehringer Ingelheim
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Eli Lilly and Company
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Summary
Brief summary
This is a study in adults with chronic heart failure. People with chronic heart failure may need to be hospitalised for their condition. Some people with chronic heart failure may eventually die from their condition. The purpose of the study is to find out whether a medicine called empagliflozin lowers the chances of patients having to go to hospital for heart failure and whether it improves their survival. The study is open to patients with a type of chronic heart failure called chronic heart failure with preserved ejection fraction. Participants stay in the study until researchers have enough information about how effective empagliflozin is. It is expected that participants who enter at the very beginning of the enrolment period may be in the study for over 3 years, while participants who enter near the end of the enrolment period may be in the study for less than 2 years. The participants are put into 2 groups. It is decided by chance who gets into which group. One group gets empagliflozin tablets every day and the other group gets placebo tablets every day. Placebo tablets look like empagliflozin tablets but contain no medicine. Participants visit the doctors regularly. During these visits, the doctors collect information about the participant's health. The doctors want to know how many patients had to go to hospital because of heart failure or who died from cardiovascular disease.
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Trial website
https://clinicaltrials.gov/study/NCT03057951
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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. Butler J, Filippatos G, Siddiqi TJ, Ferreira JP, Brueckmann M, Bocchi E, Bohm M, Chopra VK, Giannetti N, Iwata T, Januzzi JL, Kaul S, Pina IL, Ponikowski P, Rauch-Krohnert U, Shah SJ, Senni M, Sumin M, Verma S, Zhang J, Pocock SJ, Zannad F, Packer M, Anker SD. Effects of Empagliflozin in Women and Men With Heart Failure and Preserved Ejection Fraction. Circulation. 2022 Oct 4;146(14):1046-1055. doi: 10.1161/CIRCULATIONAHA.122.059755. Epub 2022 Sep 13. Filippatos G, Butler J, Farmakis D, Zannad F, Ofstad AP, Ferreira JP, Green JB, Rosenstock J, Schnaidt S, Brueckmann M, Pocock SJ, Packer M, Anker SD; EMPEROR-Preserved Trial Committees and Investigators. Empagliflozin for Heart Failure With Preserved Left Ventricular Ejection Fraction With and Without Diabetes. Circulation. 2022 Aug 30;146(9):676-686. doi: 10.1161/CIRCULATIONAHA.122.059785. Epub 2022 Jun 28. 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. Januzzi JL Jr, Butler J, Zannad F, Filippatos G, Ferreira JP, Pocock SJ, Sattar N, Verma S, Vedin O, Iwata T, Brueckmann M, Packer M, Anker SD; EMPEROR-Preserved Trial Study Group. Prognostic Implications of N-Terminal Pro-B-Type Natriuretic Peptide and High-Sensitivity Cardiac Troponin T in EMPEROR-Preserved. JACC Heart Fail. 2022 Jul;10(7):512-524. doi: 10.1016/j.jchf.2022.05.004. Epub 2022 Jun 1. Vaduganathan M, Claggett BL, Inciardi RM, Fonarow GC, McMurray JJV, Solomon SD. Estimating the Benefits of Combination Medical Therapy in Heart Failure With Mildly Reduced and Preserved Ejection Fraction. Circulation. 2022 Jun 7;145(23):1741-1743. doi: 10.1161/CIRCULATIONAHA.121.058929. Epub 2022 May 23. No abstract available. 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. Butler J, Filippatos G, Jamal Siddiqi T, Brueckmann M, Bohm M, Chopra VK, Pedro Ferreira J, Januzzi JL, Kaul S, Pina IL, Ponikowski P, Shah SJ, Senni M, Vedin O, Verma S, Peil B, Pocock SJ, Zannad F, Packer M, Anker SD. Empagliflozin, Health Status, and Quality of Life in Patients With Heart Failure and Preserved Ejection Fraction: The EMPEROR-Preserved Trial. Circulation. 2022 Jan 18;145(3):184-193. doi: 10.1161/CIRCULATIONAHA.121.057812. Epub 2021 Nov 15. Kanie T, Mizuno A, Takaoka Y, Suzuki T, Yoneoka D, Nishikawa Y, Tam WWS, Morze J, Rynkiewicz A, Xin Y, Wu O, Providencia R, Kwong JS. Dipeptidyl peptidase-4 inhibitors, glucagon-like peptide 1 receptor agonists and sodium-glucose co-transporter-2 inhibitors for people with cardiovascular disease: a network meta-analysis. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD013650. doi: 10.1002/14651858.CD013650.pub2. Anker SD, Butler J, Filippatos G, Ferreira JP, Bocchi E, Bohm M, Brunner-La Rocca HP, Choi DJ, Chopra V, Chuquiure-Valenzuela E, Giannetti N, Gomez-Mesa JE, Janssens S, Januzzi JL, Gonzalez-Juanatey JR, Merkely B, Nicholls SJ, Perrone SV, Pina IL, Ponikowski P, Senni M, Sim D, Spinar J, Squire I, Taddei S, Tsutsui H, Verma S, Vinereanu D, Zhang J, Carson P, Lam CSP, Marx N, Zeller C, Sattar N, Jamal W, Schnaidt S, Schnee JM, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Preserved Trial Investigators. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. 2021 Oct 14;385(16):1451-1461. doi: 10.1056/NEJMoa2107038. Epub 2021 Aug 27. 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
Principal investigator
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Boehringer Ingelheim
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Boehringer Ingelheim
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/51/NCT03057951/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/51/NCT03057951/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/NCT03057951
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