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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)
Scientific title
A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Secondary ID [1] 0 0
2016-002280-34
Secondary ID [2] 0 0
1245.121
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: Empagliflozin -

Placebo comparator: Placebo -


Treatment: Drugs: Empagliflozin
once daily

Treatment: Drugs: Placebo
once daily

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

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

Eligibility
Key inclusion criteria
Inclusion criteria:

* Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
* Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)

* If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
* If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
* If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
* EF = 40% and hospitalization for heart failure in the past 12 months: NTproBNP = 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
* Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
* Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
* Signed and dated written ICF (Informed Consent Form)
* Further inclusion criteria apply
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
* Heart transplant recipient, or listed for heart transplant
* Acute decompensated HF
* Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
* Symptomatic hypotension and/or a SBP < 100 mmHg
* Indication of liver disease
* Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
* History of ketoacidosis
* Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
* Currently enrolled in another investigational device or drug study
* Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Further exclusion criteria apply

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


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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
CORE Research Group - Milton
Recruitment hospital [3] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [4] 0 0
SA-Heart Ashford Specialist Centre - Ashford
Recruitment hospital [5] 0 0
Heart and Vascular Research - Fullarton
Recruitment hospital [6] 0 0
The Northern Hospital - Epping
Recruitment hospital [7] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [8] 0 0
University Hospital Geelong - Geelong
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
4064 - Milton
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5035 - Ashford
Recruitment postcode(s) [5] 0 0
5063 - Fullarton
Recruitment postcode(s) [6] 0 0
3076 - Epping
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment outside Australia
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Czechia
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Bielefeld
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India
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India
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India
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Country [203] 0 0
Japan
State/province [203] 0 0
Ehime, Matsuyama
Country [204] 0 0
Japan
State/province [204] 0 0
Ehime, Uwajima
Country [205] 0 0
Japan
State/province [205] 0 0
Fukui, Fukui
Country [206] 0 0
Japan
State/province [206] 0 0
Fukuoka, Chikushino
Country [207] 0 0
Japan
State/province [207] 0 0
Fukuoka, Fukuoka
Country [208] 0 0
Japan
State/province [208] 0 0
Fukuoka, Iizuka
Country [209] 0 0
Japan
State/province [209] 0 0
Fukuoka, Kitakyushu
Country [210] 0 0
Japan
State/province [210] 0 0
Gifu, Ogaki
Country [211] 0 0
Japan
State/province [211] 0 0
Gifu, Seki
Country [212] 0 0
Japan
State/province [212] 0 0
Hiroshima, Fukuyama
Country [213] 0 0
Japan
State/province [213] 0 0
Hiroshima, Hatsukaichi
Country [214] 0 0
Japan
State/province [214] 0 0
Hiroshima, Shobara
Country [215] 0 0
Japan
State/province [215] 0 0
Hokkaido, Hakodate
Country [216] 0 0
Japan
State/province [216] 0 0
Hokkaido, Sapporo
Country [217] 0 0
Japan
State/province [217] 0 0
Hokkaido, Tomakomai
Country [218] 0 0
Japan
State/province [218] 0 0
Hyogo, Amagasaki
Country [219] 0 0
Japan
State/province [219] 0 0
Hyogo, Himeji
Country [220] 0 0
Japan
State/province [220] 0 0
Hyogo, Kobe
Country [221] 0 0
Japan
State/province [221] 0 0
Ibaraki, Higashiibaraki-gun
Country [222] 0 0
Japan
State/province [222] 0 0
Ishikawa, Kanazawa
Country [223] 0 0
Japan
State/province [223] 0 0
Kagawa, Kanonji
Country [224] 0 0
Japan
State/province [224] 0 0
Kagawa, Takamatsu
Country [225] 0 0
Japan
State/province [225] 0 0
Kanagawa, Sagamihara
Country [226] 0 0
Japan
State/province [226] 0 0
Kanagawa, Yokohama
Country [227] 0 0
Japan
State/province [227] 0 0
Kumamoto, Kumamoto
Country [228] 0 0
Japan
State/province [228] 0 0
Kumamoto, Yatsushiro
Country [229] 0 0
Japan
State/province [229] 0 0
Kyoto, Uji
Country [230] 0 0
Japan
State/province [230] 0 0
Miyagi, Sendai
Country [231] 0 0
Japan
State/province [231] 0 0
Miyazaki, Miyazaki
Country [232] 0 0
Japan
State/province [232] 0 0
Nagano, Nakano
Country [233] 0 0
Japan
State/province [233] 0 0
Nagasaki, Omura
Country [234] 0 0
Japan
State/province [234] 0 0
Okayama, Okayama
Country [235] 0 0
Japan
State/province [235] 0 0
Okinawa, Naha
Country [236] 0 0
Japan
State/province [236] 0 0
Okinawa, Shimajiri-gun
Country [237] 0 0
Japan
State/province [237] 0 0
Okinawa, Urasoe
Country [238] 0 0
Japan
State/province [238] 0 0
Osaka, Higashiosaka
Country [239] 0 0
Japan
State/province [239] 0 0
Osaka, Osaka
Country [240] 0 0
Japan
State/province [240] 0 0
Osaka, Sakai
Country [241] 0 0
Japan
State/province [241] 0 0
Osaka, Takatsuki
Country [242] 0 0
Japan
State/province [242] 0 0
Saitama, Saitama
Country [243] 0 0
Japan
State/province [243] 0 0
Shiga, Kusatsu
Country [244] 0 0
Japan
State/province [244] 0 0
Tokushima, Tokushima
Country [245] 0 0
Japan
State/province [245] 0 0
Tokyo, Meguro-ku
Country [246] 0 0
Japan
State/province [246] 0 0
Tokyo, Ome
Country [247] 0 0
Japan
State/province [247] 0 0
Tokyo, Ota-ku
Country [248] 0 0
Japan
State/province [248] 0 0
Tokyo, Toshima-ku
Country [249] 0 0
Japan
State/province [249] 0 0
Wakayama, Tanabe
Country [250] 0 0
Japan
State/province [250] 0 0
Yamaguchi, Shimonoseki
Country [251] 0 0
Korea, Republic of
State/province [251] 0 0
Busan
Country [252] 0 0
Korea, Republic of
State/province [252] 0 0
Cheongju
Country [253] 0 0
Korea, Republic of
State/province [253] 0 0
Daejeon
Country [254] 0 0
Korea, Republic of
State/province [254] 0 0
Incheon
Country [255] 0 0
Korea, Republic of
State/province [255] 0 0
Seoul
Country [256] 0 0
Korea, Republic of
State/province [256] 0 0
Sungnam
Country [257] 0 0
Korea, Republic of
State/province [257] 0 0
Wonju
Country [258] 0 0
Mexico
State/province [258] 0 0
Aguascalientes
Country [259] 0 0
Mexico
State/province [259] 0 0
Ciudad de Mexico
Country [260] 0 0
Mexico
State/province [260] 0 0
Distrito Federal
Country [261] 0 0
Mexico
State/province [261] 0 0
Guadalajara
Country [262] 0 0
Mexico
State/province [262] 0 0
Mexico
Country [263] 0 0
Mexico
State/province [263] 0 0
Monclova
Country [264] 0 0
Mexico
State/province [264] 0 0
México
Country [265] 0 0
Mexico
State/province [265] 0 0
Nuevo Leon
Country [266] 0 0
Mexico
State/province [266] 0 0
San Juan del Rio
Country [267] 0 0
Mexico
State/province [267] 0 0
San Luis Potosi
Country [268] 0 0
Mexico
State/province [268] 0 0
Tijuana
Country [269] 0 0
Mexico
State/province [269] 0 0
Torreon
Country [270] 0 0
Mexico
State/province [270] 0 0
Zapopan
Country [271] 0 0
Netherlands
State/province [271] 0 0
Almelo
Country [272] 0 0
Netherlands
State/province [272] 0 0
Amsterdam
Country [273] 0 0
Netherlands
State/province [273] 0 0
Beverwijk
Country [274] 0 0
Netherlands
State/province [274] 0 0
Blaricum
Country [275] 0 0
Netherlands
State/province [275] 0 0
Breda
Country [276] 0 0
Netherlands
State/province [276] 0 0
Den Haag
Country [277] 0 0
Netherlands
State/province [277] 0 0
EDE
Country [278] 0 0
Netherlands
State/province [278] 0 0
Eindhoven
Country [279] 0 0
Netherlands
State/province [279] 0 0
Groningen
Country [280] 0 0
Netherlands
State/province [280] 0 0
Heerlen
Country [281] 0 0
Netherlands
State/province [281] 0 0
Hoorn
Country [282] 0 0
Netherlands
State/province [282] 0 0
Maastricht
Country [283] 0 0
Netherlands
State/province [283] 0 0
Meppel
Country [284] 0 0
Netherlands
State/province [284] 0 0
Nieuwegein
Country [285] 0 0
Netherlands
State/province [285] 0 0
Nijmegen
Country [286] 0 0
Netherlands
State/province [286] 0 0
Uden
Country [287] 0 0
Netherlands
State/province [287] 0 0
Venlo
Country [288] 0 0
Netherlands
State/province [288] 0 0
Zaandam
Country [289] 0 0
Netherlands
State/province [289] 0 0
Zutphen
Country [290] 0 0
Poland
State/province [290] 0 0
Bialystok
Country [291] 0 0
Poland
State/province [291] 0 0
Bielsko-Biala
Country [292] 0 0
Poland
State/province [292] 0 0
Bydgoszcz
Country [293] 0 0
Poland
State/province [293] 0 0
Chorzow
Country [294] 0 0
Poland
State/province [294] 0 0
Dabrowa Gornicza
Country [295] 0 0
Poland
State/province [295] 0 0
Gdansk
Country [296] 0 0
Poland
State/province [296] 0 0
Gdynia
Country [297] 0 0
Poland
State/province [297] 0 0
Katowice
Country [298] 0 0
Poland
State/province [298] 0 0
Kielce
Country [299] 0 0
Poland
State/province [299] 0 0
Krakow
Country [300] 0 0
Poland
State/province [300] 0 0
Lodz
Country [301] 0 0
Poland
State/province [301] 0 0
Lowicz
Country [302] 0 0
Poland
State/province [302] 0 0
Nysa
Country [303] 0 0
Poland
State/province [303] 0 0
Oswiecim
Country [304] 0 0
Poland
State/province [304] 0 0
Ruda Slaska
Country [305] 0 0
Poland
State/province [305] 0 0
Rzeszow
Country [306] 0 0
Poland
State/province [306] 0 0
Siedlce
Country [307] 0 0
Poland
State/province [307] 0 0
Skierniewice
Country [308] 0 0
Poland
State/province [308] 0 0
Staszow
Country [309] 0 0
Poland
State/province [309] 0 0
Torun
Country [310] 0 0
Poland
State/province [310] 0 0
Tychy
Country [311] 0 0
Poland
State/province [311] 0 0
Ustron
Country [312] 0 0
Poland
State/province [312] 0 0
Warsaw
Country [313] 0 0
Poland
State/province [313] 0 0
Warszawa
Country [314] 0 0
Poland
State/province [314] 0 0
Wroclaw
Country [315] 0 0
Poland
State/province [315] 0 0
Zgierz
Country [316] 0 0
Poland
State/province [316] 0 0
Zychlin
Country [317] 0 0
Spain
State/province [317] 0 0
Barcelona
Country [318] 0 0
Spain
State/province [318] 0 0
El Palmar
Country [319] 0 0
Spain
State/province [319] 0 0
L'Hospitalet de Llobregat
Country [320] 0 0
Spain
State/province [320] 0 0
Madrid
Country [321] 0 0
Spain
State/province [321] 0 0
Malaga
Country [322] 0 0
Spain
State/province [322] 0 0
Orense
Country [323] 0 0
Spain
State/province [323] 0 0
Santiago de Compostela
Country [324] 0 0
Spain
State/province [324] 0 0
Valladolid
Country [325] 0 0
United Kingdom
State/province [325] 0 0
Barnet
Country [326] 0 0
United Kingdom
State/province [326] 0 0
Cardiff
Country [327] 0 0
United Kingdom
State/province [327] 0 0
Eastleigh
Country [328] 0 0
United Kingdom
State/province [328] 0 0
High Wycombe
Country [329] 0 0
United Kingdom
State/province [329] 0 0
Leicester
Country [330] 0 0
United Kingdom
State/province [330] 0 0
London
Country [331] 0 0
United Kingdom
State/province [331] 0 0
Luton
Country [332] 0 0
United Kingdom
State/province [332] 0 0
Newport
Country [333] 0 0
United Kingdom
State/province [333] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Results publications and other study-related documents

No documents have been uploaded by study researchers.