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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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)
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)
Secondary ID [1] 0 0
2016-002278-11
Secondary ID [2] 0 0
1245.110
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: 10 mg 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 First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
Timepoint [1] 0 0
From randomization until completion of the planned treatment phase, up to 1403 days.
Secondary outcome [1] 0 0
Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)
Timepoint [1] 0 0
From randomization until completion of the planned treatment phase, up to 1403 days.
Secondary outcome [2] 0 0
eGFR (CKD-EPI) cr Slope of Change From Baseline
Timepoint [2] 0 0
At baseline, week 4, 12, 32, 52, 76, 100, 124, 148, 172 and week 196, up to 1043 days.
Secondary outcome [3] 0 0
Time to the First Event in the Composite Renal Endpoint: Chronic Dialysis, Renal Transplant, or Sustained Reduction in eGFR (CKD-EPI)cr
Timepoint [3] 0 0
From randomization until completion of the planned treatment phase, up to 1403 days.
Secondary outcome [4] 0 0
Time to First Adjudicated Hospitalisation for Heart Failure (HHF)
Timepoint [4] 0 0
From randomization until completion of the planned treatment phase, up to 1403 days.
Secondary outcome [5] 0 0
Time to Adjudicated Cardiovascular (CV) Death
Timepoint [5] 0 0
From randomization until completion of the planned treatment phase, up to 1403 days.
Secondary outcome [6] 0 0
Time to All-cause Mortality
Timepoint [6] 0 0
From randomization until completion of the planned treatment phase, up to 1403 days.
Secondary outcome [7] 0 0
Time to Onset of Diabetes Mellitus (DM) in Patients With Pre-DM
Timepoint [7] 0 0
From randomization until completion of the planned treatment phase, to 1403 days.
Secondary outcome [8] 0 0
Change From Baseline in Kansas City Cardiomyopathy Questionaire (KCCQ) Clinical Summary Score at Week 52
Timepoint [8] 0 0
At baseline and at week 12, week 32 and week 52.
Secondary outcome [9] 0 0
Occurrence of All-cause Hospitalisation (First and Recurrent)
Timepoint [9] 0 0
From randomization until completion of the planned treatment phase, up to 1403 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 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
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 (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

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
2/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/04/2021
Sample size
Target
Accrual to date
Final
5988
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pendlebury Research - Kotara
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [3] 0 0
CORE Research Group - Milton
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Gold Coast University Hospital - Southport
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Royal Adelaide Hospital - Adelaide
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Adelaide Medical Research - Ashford
Recruitment hospital [7] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [8] 0 0
Heart and Vascular Research - Fullarton
Recruitment hospital [9] 0 0
The Queen Elizabeth Hospital - Woodville South
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The Northern Hospital - Epping
Recruitment hospital [11] 0 0
Peninsula Private Hospital - Frankston
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University Hospital Geelong - Geelong
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Mount Hospital - Perth
Recruitment postcode(s) [1] 0 0
2289 - Kotara
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2305 - New Lambton Heights
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4064 - Milton
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4215 - Southport
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5000 - Adelaide
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5035 - Ashford
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5042 - Bedford Park
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5063 - Fullarton
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5011 - Woodville South
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3076 - Epping
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3199 - Frankston
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3220 - Geelong
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6000 - Perth
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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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03057951
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03057951