Cardiovascular Atlas
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EMPEROR-Preserved

A large trial in adults with heart failure and an ejection fraction above 40%. About half were given empagliflozin 10 mg once a day and half a placebo, on top of usual treatment. Over a median of about 26 months, fewer people on empagliflozin died from cardiovascular causes or were admitted to hospital for heart failure. The authors say this effect was mainly due to fewer hospital admissions for heart failure. Genital and urinary tract infections and low blood pressure were reported more often with empagliflozin.

Also called Empagliflozin outcome trial in heart failure with preserved 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 usual therapy in people with an ejection fraction above 40%. The abstract calls it double-blind and the registry records masking as double.
Phase
Phase 3
Enrolled
  • 5,988 patients (randomized count) (Empagliflozin in Heart Failure with a Preserved Ejection Fraction, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT03057951
Started
(actual) (EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved), retrieved )
Primary completion
(actual) (EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved), retrieved )
Completion
(actual) (EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved), retrieved )
Results first posted
(actual) (EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved), retrieved )
Countries
United States, Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Czechia, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, Romania, Singapore, South Africa, South Korea, Spain, United Kingdom (EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved), 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 (NCT03057951) of 5988 patients with NYHA class II to IV heart failure and an ejection fraction of more than 40%. Primary outcome: cardiovascular death or hospitalization for heart failure, hazard ratio 0.79 (95% CI 0.69 to 0.90) over a median of 26.2 months, from the PubMed abstract. The abstract says the effect was mainly related to a lower risk of hospitalization for heart failure. The registry title and official title say preserved ejection fraction; the abstract entry criterion is an ejection fraction above 40%, so the trial includes people whom NHLBI would call borderline (41% to 49%). 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 usual therapy (abstract). The registry labels the arm 10 mg Empagliflozin.

  • Placebo

    Intervention None named

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

Findings

No findings are published for this study.

Record details

Record id
cardio:emperor-preserved
Content hash
685026da9e42dc7b762bef1de038ef463fc629154ba32b168795dd3df4292d40