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EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced) | Clinical Trials | Clareo Health

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

A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

NCT03057977•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patient age \>= 18 years at screening. For Japan only: Age \>= 20 years at screening
•Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) \<=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
•* If EF \>= 36% to \<= 40%: NT-proBNP \>= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP \>= 5000 pg/ml for patients with AF
•* If EF \>= 31% to \<= 35%: NT-proBNP \>= 1000 pg/ml for patients without AF and NT-proBNP \>=2000 pg/ml for patients with AF
•* If EF\<= 30%: NT-proBNP \>= 600 pg/ml for patients without AF and NT-proBNP \>=1200 pg/ml for patients with AF
•* EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP \>= 1200 pg/ml for patients with AF
•Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
•Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
•Signed and dated written ICF (Informed Consent Form)

Exclusion Criteria

•Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
•Heart transplant recipient, or listed for heart transplant
•Acute decompensated HF
•Systolic blood pressure (SBP) \>= 180 mmHg at Visit 2.
•Symptomatic hypotension and/or a SBP \< 100 mmHg
•Indication of liver disease
•Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) \< 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
•History of ketoacidosis
•Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
•Currently enrolled in another investigational device or drug study
+2 more criteria

Locations (520)

La Mesa Cardiac Center

La Mesa, California, United States

Long Beach Center for Clinical Research

Long Beach, California, United States

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

Merced Vein and Vascular Center

Merced, California, United States

University of California Irvine

Orange, California, United States

Covigilant Research, LLC

Riverside, California, United States

University of California

Torrance, California, United States

Orange County Research Center

Tustin, California, United States

Blue Coast Cardiology

Vista, California, United States

South Denver Cardiology Associates, PC

Littleton, Colorado, United States

Key Dates

Start Date

March 6, 2017

Primary Completion Date

May 1, 2020

Completion Date

May 28, 2020

Last Updated

May 18, 2021

Enrollment

3,730

ACTUAL participants

Conditions

Heart Failure

Interventions

Empagliflozin

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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