1245.110 EMPEROR-Preserved Study
Research type
Research Study
Full 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).
IRAS ID
221776
Contact name
Iain Squire
Contact email
Sponsor organisation
Boehringer Ingelheim International GmbH
Eudract number
2016-002278-11
Duration of Study in the UK
4 years, 7 months, 1 days
Research summary
This is a phase III study in patients with symptomatic chronic heart failure (HF) with preserved ejection fraction (Left Ventricular Ejection Fraction >40%) called EMPEROR-Preserved. Patients will receive either study drug Empagliflozin or placebo (dummy drug). Phase III means the study drug has been tested in patients before. The study drug was originally developed for treatment of Type 2 diabetes, and is licensed for this use in several countries including the EU and America under the name Jardiance™. This study will collect further information for the use of the drug in HF treatment.
The aim of the study is to find out if the study drug is better than the placebo in treating HF. The study is randomised, you cannot choose if you get study drug or placebo. It is allocated 1:1 at random like flipping a coin. It is also double-blinded so neither the patient nor the doctor know if study drug or placebo is being given; the doctor can find it out in an emergency though.
Regardless of being on placebo or empagliflozin the patient's doctors (GP and hospital) are able to change all other treatments, including heart failure medications, as needed, to control the patients’ symptoms of HF.
The placebo/study drug will be taken once a day by mouth. The study will involve approximately 12 visits to hospital and 6 phone calls. The study could last up to 38 months, but it could also end earlier or last longer, depending on how long it takes to collect the information required for the trial.
Approximately 4126 patients at 500 study centres across approximately 22 countries will take part in this study. The number of patients randomised may be increased up to 6000.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0058
Date of REC Opinion
25 Apr 2017
REC opinion
Further Information Favourable Opinion