Phase 3
N=3,730
EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03057977 ↗Enrolled (actual)
3,730
Serious AEs
44.8%
Results posted
May 2021
Primary outcome: Primary: Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) — 21.00; 15.77 Patients with events/ 100 pt-yrs at risk — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Empagliflozin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) |
21.00; 15.77 | <0.0001 sig |
| SECONDARY Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent) |
553; 388 | 0.0003 sig |
| SECONDARY eGFR (CKD-EPI) cr Slope of Change From Baseline |
-2.278; -0.546 | <0.0001 sig |
| SECONDARY Time to First Event in Composite Renal Endpoint: Chronic Dialysis, Renal Transplant or Sustained Reduction of eGFR(CKD-EPI)cr |
3.07; 1.56 | 0.0019 sig |
| SECONDARY Time to First Adjudicated Hospitalisation for Heart Failure (HHF) |
15.55; 10.75 | <0.0001 sig |
| SECONDARY Time to Adjudicated Cardiovascular (CV) Death |
8.13; 7.55 | 0.4133 |
| SECONDARY Time to All-cause Mortality |
10.71; 10.06 | 0.3536 |
| SECONDARY Time to Onset of Diabetes Mellitus (DM) |
10.62; 9.31 | 0.3576 |
| SECONDARY Change From Baseline in KCCQ (Kansas City Cardiomyopathy Questionnaire) Clinical Summary Score at Week 52 |
-3.36; -1.30 | 0.0340 sig |
| SECONDARY Number of All-cause Hospitalizations (First and Recurrent) |
1570; 1364 | 0.0065 sig |
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 Criteria
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) = 36% to = 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 = 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
- If EF = 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)
- Further inclusion criteria apply
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
- Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT03057977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.