These trials will evaluate the effect of Jardiance on exercise ability and heart failure symptoms in people with chronic heart failure independent of whether they have type 2 diabetes.
EMPERIAL comprises two Phase III trials that will assess the effect of 12 weeks of treatment with Jardiance on the ability of people with heart failure to perform daily exercise.
The plans for the EMPERIAL trials follow initiation of the EMPEROR trials in March 2017. While the EMPEROR outcome trials focus on long-term morbidity and mortality outcomes in people with heart failure, the EMPERIAL functional trials will investigate possible benefits on exercise capacity and heart failure symptoms.
These studies are based on data obtained from the landmark EMPA-REG OUTCOME® trial, where the effect of Jardiance on heart failure outcomes was evaluated.
Lilly Diabetes product development vice president Dr Jeff Emmick said: "Symptoms of heart failure can have a profound effect on quality of life, with more than three-quarters of people with heart failure finding it difficult to carry out routine activities.
"Currently, there are limited treatment options that can help improve the everyday lives of people living with chronic heart failure. We look forward to seeing whether Jardiance can help address this unmet need."
Heart failure is a serious condition where the heart is unable to pump enough blood around the body. It affects 26 million people worldwide, including more than 6 million Americans, and is associated with high morbidity and mortality. Approximately 50 percent of people who develop heart failure die within five years, and it is a leading cause of hospitalization in the United States and Europe.
EMPERIAL consists of two Phase III randomized, double-blind trials. The trials evaluate the effect of 12 weeks' treatment of once-daily Jardiance 10 mg compared with placebo on exercise ability and heart failure symptoms in patients with chronic heart failure with preserved or reduced ejection fraction.* This will be measured by the 6-minute walk test, a common measure of functional exercise capacity.
EMPERIAL-preserved [NCT03448406]: will investigate Jardiance in patients with chronic heart failure with preserved ejection fraction (HFpEF). The study looks at a functional endpoint — how far patients can walk in 6 minutes — and at heart failure symptoms.
Primary endpoint: Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes
Anticipated number of patients: approx. 300
Estimated completion: 2019
EMPERIAL-reduced [NCT03448419]: will investigate Jardiance in patients with chronic heart failure with reduced ejection fraction (HFrEF). The study looks at a functional endpoint — how far patients can walk in 6 minutes — and at heart failure symptoms.
Primary endpoint: Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes
Anticipated number of patients: approx. 300
Estimated completion: 2019