EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)
- Registration Number
- NCT03057977
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3730
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empagliflozin Empagliflozin - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) From randomisation until completion of the planned treatment period, up to 1040 days. Time to the first event of adjudicated cardiovascular (CV) death or adjudicated hospitalisation for heart failure (HHF). The incidence rate per 100 patient years (100 \* number of patients with event /time at risk \[years\]) is presented. With time at risk \[year\] calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.
Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.
- Secondary Outcome Measures
Name Time Method Number of All-cause Hospitalizations (First and Recurrent) From randomisation until completion of the planned treatment phase, up to 1040 days. Number of all-cause hospitalizations (first and recurrent).
Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent) From randomisation until completion of the planned treatment phase, up to 1040 days. Reported is the total number of HHF events (first and recurrent) which occurred.
All data up to the end of the planned treatment period (including the data after the end of treatment for patients not completing the treatment period as planned) from all randomised patients was used.eGFR (CKD-EPI) cr Slope of Change From Baseline Assessed at baseline, week 4, 12, 32, 52, 76, 100, 124, 148 and at end of treatment (EOT), up to 1040 days. Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) \[mL/min/1.73m2\] slope of change from baseline.
Available on-treatment change-from-baseline data were to be used. Patients without on-treatment data after randomisation were not to be included in this analysis. Slope represents the long term effect on eGFR.
Timepoints after baseline were included in calculation of slope of change from baseline. Descriptive statistic (mean(standard error)) is reported.Time to First Event in Composite Renal Endpoint: Chronic Dialysis, Renal Transplant or Sustained Reduction of eGFR(CKD-EPI)cr From randomisation until completion of the planned treatment period, up to 1040 days. Time to the first event in the composite renal endpoint: chronic dialysis (with a frequency of twice per week or more for at least 90 days), renal transplant, or sustained reduction in Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr).
The incidence rate per 100 patient years (100 \* number of patients with event /time at risk \[years\]) is presented. With time at risk \[year\] calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.
Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.Time to First Adjudicated Hospitalisation for Heart Failure (HHF) From randomisation until completion of the planned treatment period, up to 1040 days. Time to first adjudicated Hospitalisation for Heart Failure (HHF). The incidence rate per 100 patient years (100 \* number of patients with event /time at risk \[years\]) is presented. With time at risk \[year\] calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25. Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.
Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.Time to Adjudicated Cardiovascular (CV) Death From randomisation until completion of the planned treatment period, up to 1040 days. Time to adjudicated CV (Cardiovascular) death. The incidence rate (patients with events per 100 person years at risk) is reported.
The incidence rate per 100 patient years (100 \* number of patients with event /time at risk \[years\]) is presented. With time at risk \[year\] calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.
Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.Time to All-cause Mortality From randomisation until completion of the planned treatment period, up to 1040 days. Time to all-cause mortality. The incidence rate (patients with events per 100 person years at risk) is reported.
The incidence rate per 100 patient years (100 \* number of patients with event /time at risk \[years\]) is presented. With time at risk \[year\] calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.
Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.Time to Onset of Diabetes Mellitus (DM) From randomisation until completion of the planned treatment period, up to 1040 days. Time to onset of DM (Glycated haemoglobin (HbA1c) ≥6.5% or as diagnosed by the investigator) in patients with pre-DM (no history of DM and no HbA1c ≥6.5% before treatment, and a pre-treatment HbA1c value of 5.7 to \<6.5%). The incidence rate (patients with events per 100 person years at risk) is reported.
The incidence rate per 100 patient years (100 \* number of patients with event /time at risk \[years\]) is presented. With time at risk \[year\] calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.
Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.Change From Baseline in KCCQ (Kansas City Cardiomyopathy Questionnaire) Clinical Summary Score at Week 52 Assessed at baseline, week 12, week 32 and week 52. Change from baseline in KCCQ (Kansas City cardiomyopathy questionnaire) clinical summary score at Week 52. The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, selfefficacy, and quality of life in patients with Heart Failure. The KCCQ-clinical summary score comprises the following domains: Symptom frequency, symptom burden and physical limitation. The score is calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.
For patients who died, a worst score (score of 0) is imputed at all subsequent scheduled visits after the date of death.
Standard error is adjusted standard error. Change from baseline in KCCQ-score at week 52 was modeled using a MMRM with visit (week 12, 32 and 52) as repeated measures, adjusted mean (standard error) at week 52 is reported.
Trial Locations
- Locations (514)
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
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