Cardiovascular Atlas
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EMPEROR-Reduced

A large trial in adults with heart failure and a reduced ejection fraction (40% or less) who were already taking recommended treatment. About half were given empagliflozin 10 mg once a day and half a placebo. Over a median of 16 months, fewer people on empagliflozin died from cardiovascular causes or were admitted to hospital for worsening heart failure. The authors report the effect was consistent in people with and without diabetes.

Also called Empagliflozin outcome trial in heart failure with reduced ejection fraction

  • Study
  • In this atlas

Overview

Design
Randomized, parallel-group, double-blind, placebo-controlled phase 3 trial of empagliflozin 10 mg once daily added to recommended therapy. The abstract calls it double-blind and the registry records masking as double.
Phase
Phase 3
Enrolled
  • 3,730 patients (randomized count) (Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT03057977
Started
(actual) (EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced), retrieved )
Primary completion
(actual) (EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced), retrieved )
Completion
(actual) (EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced), retrieved )
Results first posted
(actual) (EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced), retrieved )
Countries
United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, South Korea, Spain, United Kingdom (EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced), retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Boehringer Ingelheim-sponsored (Eli Lilly and Company is a registry collaborator), randomized, double-blind, placebo-controlled phase 3 trial (NCT03057977) of 3730 patients with NYHA class II to IV heart failure and an ejection fraction of 40% or less. Primary outcome: cardiovascular death or hospitalization for worsening heart failure, hazard ratio 0.75 (95% CI 0.65 to 0.86) over a median of 16 months, from the PubMed abstract. The registry condition field says only heart failure; the registry title names reduced ejection fraction. The full text was not read. Funding is stated in the abstract as Boehringer Ingelheim and Eli Lilly.

Arms

  • Empagliflozin

    Intervention Empagliflozin

    Empagliflozin 10 mg once daily, added to recommended therapy (abstract).

  • Placebo

    Intervention None named

    Placebo, added to recommended therapy (abstract and registry).

Findings

No findings are published for this study.

Record details

Record id
cardio:emperor-reduced
Content hash
5706b5e60f4fc3bd3b3464a14b037c3eea5f43ec119b9bf9322c92140f5421fc