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)
Overview
- Phase
- Phase 3
- Intervention
- Empagliflozin
- Conditions
- Heart Failure
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 3730
- Locations
- 514
- Primary Endpoint
- Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Empagliflozin
Intervention: Empagliflozin
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
Time Frame: 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 Outcomes
- Number of All-cause Hospitalizations (First and Recurrent)(From randomisation until completion of the planned treatment phase, up to 1040 days.)
- Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)(From randomisation until completion of the planned treatment phase, up to 1040 days.)
- 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.)
- 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 First Adjudicated Hospitalisation for Heart Failure (HHF)(From randomisation until completion of the planned treatment period, up to 1040 days.)
- Time to Adjudicated Cardiovascular (CV) Death(From randomisation until completion of the planned treatment period, up to 1040 days.)
- Time to All-cause Mortality(From randomisation until completion of the planned treatment period, up to 1040 days.)
- Time to Onset of Diabetes Mellitus (DM)(From randomisation until completion of the planned treatment period, up to 1040 days.)
- 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.)