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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
6/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/05/2020
Sample size
Target
Accrual to date
Final
3730
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
CORE Research Group - Milton
Recruitment hospital [3] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [4] 0 0
SA-Heart Ashford Specialist Centre - Ashford
Recruitment hospital [5] 0 0
Heart and Vascular Research - Fullarton
Recruitment hospital [6] 0 0
The Northern Hospital - Epping
Recruitment hospital [7] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [8] 0 0
University Hospital Geelong - Geelong
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
4064 - Milton
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5035 - Ashford
Recruitment postcode(s) [5] 0 0
5063 - Fullarton
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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State/province [201] 0 0
Chiba, Kisarazu
Country [202] 0 0
Japan
State/province [202] 0 0
Chiba, Matsudo
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.

Results are available at https://clinicaltrials.gov/study/NCT03057977