Trial · NCT03057977
EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)
NCT03057977, Phase 3, Completed, Boehringer Ingelheim; results first posted 2021-05-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced). Trials, record NCT03057977. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03057977
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)
- NCT number
- NCT03057977
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,730 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Heart Failure
- Interventions
- Empagliflozin, Placebo
- First posted
- 2017-02-20
- Last updated
- 2021-05-18
- Other registries' IDs
- eudract:2016-002280-34
- Results first posted
- 2021-05-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | Randomised Set: All randomised patients. | Patients with events/ 100 pt-yrs at risk | NUMBER |
| SECONDARY | Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent) | From randomisation until completion of the planned treatment phase, up to 1040 days. | Randomised Set (RS): All randomised patients. | HHF events | NUMBER |
| SECONDARY | 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. | Treated Set (TS): All patients treated with at least one dose of the study medication and at least one on-treatment measurement of eGFR. | Milliliter/minute/1.73 meters squared | MEAN |
| SECONDARY | 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. | Randomised Set: All randomised patients. | Patients with events/ 100 pt-yrs at risk | NUMBER |
| SECONDARY | Time to First Adjudicated Hospitalisation for Heart Failure (HHF) | From randomisation until completion of the planned treatment period, up to 1040 days. | Randomised Set (RS): All randomised patients. | Patients with events/ 100 pt-yrs at risk | NUMBER |
| SECONDARY | Time to Adjudicated Cardiovascular (CV) Death | From randomisation until completion of the planned treatment period, up to 1040 days. | Randomised Set: All randomised patients. | Patients with events/ 100 pt-yrs at risk | NUMBER |
| SECONDARY | Time to All-cause Mortality | From randomisation until completion of the planned treatment period, up to 1040 days. | Randomised Set: All randomised patients. | Patients with events/ 100 pt-yrs at risk | NUMBER |
| SECONDARY | Time to Onset of Diabetes Mellitus (DM) | From randomisation until completion of the planned treatment period, up to 1040 days. | Patients in the randomised set with pre-DM. | Patients with events/ 100 pt-yrs at risk | NUMBER |
| SECONDARY | 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. | Patients in the randomized set (RS) with available data for this endpoint, including values obtained on treatment or post-treatment. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of All-cause Hospitalizations (First and Recurrent) | From randomisation until completion of the planned treatment phase, up to 1040 days. | Randomised Set: All randomised patients. | Hospitalizations for any cause | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) | Placebo | 21.00 | 95% Confidence Interval 19.13 to 22.96 | Patients with events/ 100 pt-yrs at risk | |
| Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) | 10 mg Empagliflozin | 15.77 | 95% Confidence Interval 14.19 to 17.44 | Patients with events/ 100 pt-yrs at risk | |
| Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent) | Placebo | 553 | HHF events | ||
| Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent) | 10 mg Empagliflozin | 388 | HHF events | ||
| eGFR (CKD-EPI) cr Slope of Change From Baseline | Placebo | -2.278 | Standard Error 0.229 | Milliliter/minute/1.73 meters squared | |
| eGFR (CKD-EPI) cr Slope of Change From Baseline | 10 mg Empagliflozin | -0.546 | Standard Error 0.227 | Milliliter/minute/1.73 meters squared | |
| Time to First Event in Composite Renal Endpoint: Chronic Dialysis, Renal Transplant or Sustained Reduction of eGFR(CKD-EPI)cr | Placebo | 3.07 | 95% Confidence Interval 2.33 to 3.91 | Patients with events/ 100 pt-yrs at risk | |
| Time to First Event in Composite Renal Endpoint: Chronic Dialysis, Renal Transplant or Sustained Reduction of eGFR(CKD-EPI)cr | 10 mg Empagliflozin | 1.56 | 95% Confidence Interval 1.06 to 2.17 | Patients with events/ 100 pt-yrs at risk | |
| Time to First Adjudicated Hospitalisation for Heart Failure (HHF) | Placebo | 15.55 | 95% Confidence Interval 13.94 to 17.24 | Patients with events/ 100 pt-yrs at risk | |
| Time to First Adjudicated Hospitalisation for Heart Failure (HHF) | 10 mg Empagliflozin | 10.75 | 95% Confidence Interval 9.45 to 12.13 | Patients with events/ 100 pt-yrs at risk |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Discontinuation From Treatment | STARTED | Placebo | 1,867 | |
| Discontinuation From Treatment | STARTED | 10 mg Empagliflozin | 1,863 | |
| Discontinuation From Treatment | Treated | Placebo | 1,863 | |
| Discontinuation From Treatment | Treated | 10 mg Empagliflozin | 1,863 | |
| Discontinuation From Treatment | COMPLETED | Placebo | 1,352 | |
| Discontinuation From Treatment | COMPLETED | 10 mg Empagliflozin | 1,381 | |
| Discontinuation From Treatment | NOT COMPLETED | Placebo | 515 | |
| Discontinuation From Treatment | NOT COMPLETED | 10 mg Empagliflozin | 482 | |
| Discontinuation From Trial | STARTED | Placebo | 1,867 | |
| Discontinuation From Trial | STARTED | 10 mg Empagliflozin | 1,863 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events1,170
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Placebo | 94 | 1,863 | |
| other | Nasopharyngitis | Infections and infestations | 10 mg Empagliflozin | 89 | 1,863 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Placebo | 109 | 1,863 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | 10 mg Empagliflozin | 99 | 1,863 | |
| other | Hyperuricaemia | Metabolism and nutrition disorders | Placebo | 115 | 1,863 | |
| other | Hyperuricaemia | Metabolism and nutrition disorders | 10 mg Empagliflozin | 63 | 1,863 | |
| other | Hypotension | Vascular disorders | Placebo | 109 | 1,863 | |
| other | Hypotension | Vascular disorders | 10 mg Empagliflozin | 120 | 1,863 | |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo | 6 | 1,863 | |
| serious | Anaemia | Blood and lymphatic system disorders | 10 mg Empagliflozin | 10 | 1,863 |
1 to 10 of 1,170Source ClinicalTrials.gov
See all 1,170 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 266 | 1,867 |
| Total, all-cause mortality | 10 mg Empagliflozin | 249 | 1,863 |
| Total, other adverse events | Placebo | 369 | 1,863 |
| Total, other adverse events | 10 mg Empagliflozin | 328 | 1,863 |
| Total, serious adverse events | Placebo | 896 | 1,863 |
| Total, serious adverse events | 10 mg Empagliflozin | 772 | 1,863 |
Source ClinicalTrials.gov
Papers31
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 10 mg Empagliflozin vs Placebo: deaths from any cause | Trial comparisons |
| 10 mg Empagliflozin vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03057977
GET https://conductscience.org/api/trials/v1/NCT03057977/events?page=2