drugset / Trial / NCT03057951

EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)

Phase 3 Completed 5988 enrolled Boehringer Ingelheim Eli Lilly and Company · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start: 2017-03-02
Primary completion: 2021-04-26
Completion: 2021-04-26

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs 10 mg Empagliflozin; p = 0.0003; Hazard Ratio (HR) 0.79 NCT03057951 ↗

paper Empagliflozin reduced the combined risk of cardiovascular death or hospitalization for heart failure PMID 34449189 ↗

release “Full results from the landmark EMPEROR-Preserved phase III trial demonstrated that Jardiance® (empagliflozin) showed an impressive 21% relative risk reduction for the composite primary endpoint” lilly.com ↗

release “EMPEROR-Preserved showed that Jardiance significantly reduced the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure” lilly.com ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Empagliflozin	Small molecule	10 mg	Oral