Available datapackage for study '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)'

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.