Boehringer and Eli Lilly expand heart failure program for Jardiance.

Boehringer Ingelheim and Lilly expand heart failure program for Jardiance with new exercise capacity trials : Boehringer Ingelheim and Eli Lilly and Company announced plans to expand their clinical trial program for Jardiance in chronic heart failure with the EMPERIAL clinical trials. 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.

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.

Ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. During each heart beat pumping cycle, the heart contracts and relaxes. When the heart contracts, it ejects blood from the two pumping chambers (ventricles). When the heart relaxes, the ventricles refill with blood.