Boehringer Ingelheim and Eli Lilly are set to expand their existing clinical trial programme for empagliflozin in chronic heart failure with new exercise capacity trials.
The EMPERIAL trials are designed to examine the effect of empagliflozin on exercise ability and heart failure symptoms in people with chronic heart failure, regardless of whether they have type 2 diabetes. The studies are scheduled to be completed next year.
The trials feature two Phase III randomised, double-blind studies, EMPERIAL-preserved (NCT03448406) and EMPERIAL-reduced (NCT03448419).
Both trials are set to assess the effect of 12 weeks’ treatment with empagliflozin on the ability of people with heart failure to perform daily exercise.
EMPERIAL-preserved is expected to examine empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF).
The trial’s primary endpoint includes change from baseline to week 12 in exercise capacity as measured by the distance walked in six minutes. It aims to enrol around 300 patients, with plans to do the same next year.
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EMPERIAL-reduced will examine empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF).
The primary endpoint of the trial is the change from baseline to week 12 in exercise capacity as measured by the distance walked in six minutes.
Lilly Diabetes Product Development vice-president 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.”
Heart failure, a serious condition where the heart is unable to pump enough blood around the body, is estimated to affect 26 million people worldwide. Roughly 50% of those who develop heart failure die within five years.