Trial · NCT03057951
EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
NCT03057951, Phase 3, Completed, Boehringer Ingelheim; results first posted 2022-06-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved). Trials, record NCT03057951. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03057951
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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 Preserved Ejection Fraction (EMPEROR-Preserved)
- NCT number
- NCT03057951
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,988 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Heart Failure
- Interventions
- Empagliflozin, Placebo
- First posted
- 2017-02-20
- Last updated
- 2022-06-06
- Other registries' IDs
- eudract:2016-002278-11
- Results first posted
- 2022-06-06
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 First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) | From randomization until completion of the planned treatment phase, up to 1403 days. | Failure with preserved Ejection Fraction (HFpEF). The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed: Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\]. Time at risk \[years\] = 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. |
| Secondary | Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent) | From randomization until completion of the planned treatment phase, up to 1403 days. | Reported is the total number of adjudicated HHF events (first and recurrent) which occurred. |
| Secondary | eGFR (CKD-EPI) cr Slope of Change From Baseline | At baseline, week 4, 12, 32, 52, 76, 100, 124, 148, 172 and week 196, up to 1043 days. | Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR(CKD-EPI)cr) slope of change from baseline. Available on-treatment change-from-baseline data were used. The slope represents the long term effect of eGFR change from baseline and provides the yearly rate of decline. Timepoints after baseline were included in calculation of slope of change from baseline. The slope per patient was calculated using a random coefficient model with terms for treatment, region, baseline status of diabetes, age, sex, left ventricular ejection fraction (LVEF) and glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)cr) at baseline and in addition the factors "time", "treatment-by-time interaction", and "baseline eGFR (CKD-EPI)cr-by-time interaction". |
| Secondary | Time to the First Event in the Composite Renal Endpoint: Chronic Dialysis, Renal Transplant, or Sustained Reduction in eGFR (CKD-EPI)cr | From randomization until completion of the planned treatment phase, up to 1403 days. | Chronic dialysis was defined as dialysis with a frequency of twice per week or more for at least 90 days. Sustained was determined by two or more consecutive post-baseline central laboratory measurement separated by at least 30 days. Reduction in glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) was defined as reduction in eGFR from baseline ≥40%, eGFR \<15 mL/min/1.73 m\^2 for patients with baseline eGFR ≥30 mL/min/1.73 m\^2, or eGFR \<10 mL/min/1.73 m\^2 for patients with baseline eGFR \<30 mL/min/1.73 m\^2. The incidence rate per 100 patient years (100 \* number of patients with event / time at risk \[years\]) is reported. Time at risk \[year\] is calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25. Abbreviation: Patient-years (pt-yrs). |
| Secondary | Time to First Adjudicated Hospitalisation for Heart Failure (HHF) | From randomization until completion of the planned treatment phase, up to 1403 days. | Time to first adjudicated HHF. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed: Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\]. Time at risk \[years\] = 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. |
| Secondary | Time to Adjudicated Cardiovascular (CV) Death | From randomization until completion of the planned treatment phase, up to 1403 days. | Time to adjudicated CV death. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed: Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\]. Time at risk \[years\] = 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. |
| Secondary | Time to All-cause Mortality | From randomization until completion of the planned treatment phase, up to 1403 days. | Time to all-cause mortality. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed: Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\]. Time at risk \[years\] = 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. |
| Secondary | Time to Onset of Diabetes Mellitus (DM) in Patients With Pre-DM | From randomization until completion of the planned treatment phase, to 1403 days. | Time to onset of DM (defined as HbA1c ≥6.5% or as diagnosed by the investigator) in patients with pre-DM. Pre-DM was defined as no history of DM and no HbA1c ≥6.5% before treatment, and a pre-treatment HbA1c value of ≥5.7% and \<6.5%. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed: Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\]. Time at risk \[years\] = 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. |
| Secondary | Change From Baseline in Kansas City Cardiomyopathy Questionaire (KCCQ) Clinical Summary Score at Week 52 | At baseline and at week 12, week 32 and 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, self-efficacy, 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) was imputed for the score at all subsequent scheduled visits after the date of death where the score would have been assessed. 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 | Occurrence of All-cause Hospitalisation (First and Recurrent) | From randomization until completion of the planned treatment phase, up to 1403 days. | Occurrence of all-cause hospitalisation (first and recurrent). Total number of all cause hospitalisations is reported. |
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 First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) | From randomization until completion of the planned treatment phase, up to 1403 days. | Randomised Set (RS), including all randomised patients. | Patients with event/100 pt-yrs at risk | NUMBER |
| SECONDARY | Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent) | From randomization until completion of the planned treatment phase, up to 1403 days. | Randomised Set (RS), including all randomised patients. | HHF events | NUMBER |
| SECONDARY | eGFR (CKD-EPI) cr Slope of Change From Baseline | At baseline, week 4, 12, 32, 52, 76, 100, 124, 148, 172 and week 196, up to 1043 days. | Only patients included in the treated set (TS) and with available data for this endpoint. | mL/min/ 1.73 meters squared/year | MEAN |
| SECONDARY | Time to the First Event in the Composite Renal Endpoint: Chronic Dialysis, Renal Transplant, or Sustained Reduction in eGFR (CKD-EPI)cr | From randomization until completion of the planned treatment phase, up to 1403 days. | Randomised Set (RS), including all randomised patients. | Patients with event /100 pt-yrs at risk | NUMBER |
| SECONDARY | Time to First Adjudicated Hospitalisation for Heart Failure (HHF) | From randomization until completion of the planned treatment phase, up to 1403 days. | Randomised Set (RS), including all randomised patients. | Patients with event /100 pt-yrs at risk | NUMBER |
| SECONDARY | Time to Adjudicated Cardiovascular (CV) Death | From randomization until completion of the planned treatment phase, up to 1403 days. | Randomised Set (RS), including all randomised patients. | Patients with event /100 pt-yrs at risk | NUMBER |
| SECONDARY | Time to All-cause Mortality | From randomization until completion of the planned treatment phase, up to 1403 days. | Randomised Set (RS), including all randomised patients. | Patients with event /100 pt-yrs at risk | NUMBER |
| SECONDARY | Time to Onset of Diabetes Mellitus (DM) in Patients With Pre-DM | From randomization until completion of the planned treatment phase, to 1403 days. | Randomised Set (RS), including all randomised patients and with available data for this endpoint. | Patients with event /100 pt-yrs at risk | NUMBER |
| SECONDARY | Change From Baseline in Kansas City Cardiomyopathy Questionaire (KCCQ) Clinical Summary Score at Week 52 | At baseline and at week 12, week 32 and week 52. | Only Patients included in the treated set (TS) including values obtained on treatment. The number of patients analysed displays the number of patients with available data at the timepoint of interests. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Occurrence of All-cause Hospitalisation (First and Recurrent) | From randomization until completion of the planned treatment phase, up to 1403 days. | Randomised Set (RS), including all randomised patients. | Events of all-cause hospitialisations | 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 First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) | Placebo | 8.67 | 95% Confidence Interval 7.94 to 9.44 | Patients with event/100 pt-yrs at risk | |
| Time to First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) | 10 mg Empagliflozin | 6.86 | 95% Confidence Interval 6.22 to 7.54 | Patients with event/100 pt-yrs at risk | |
| Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent) | Placebo | 541 | HHF events | ||
| Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent) | 10 mg Empagliflozin | 407 | HHF events | ||
| eGFR (CKD-EPI) cr Slope of Change From Baseline | Placebo | -2.616 | Standard Deviation 0.108 | mL/min/ 1.73 meters squared/year | |
| eGFR (CKD-EPI) cr Slope of Change From Baseline | 10 mg Empagliflozin | -1.253 | Standard Deviation 0.108 | mL/min/ 1.73 meters squared/year | |
| Time to the First Event in the Composite Renal Endpoint: Chronic Dialysis, Renal Transplant, or Sustained Reduction in eGFR (CKD-EPI)cr | Placebo | 2.23 | 95% Confidence Interval 1.84 to 2.66 | Patients with event /100 pt-yrs at risk | |
| Time to the First Event in the Composite Renal Endpoint: Chronic Dialysis, Renal Transplant, or Sustained Reduction in eGFR (CKD-EPI)cr | 10 mg Empagliflozin | 2.13 | 95% Confidence Interval 1.74 to 2.54 | Patients with event /100 pt-yrs at risk | |
| Time to First Adjudicated Hospitalisation for Heart Failure (HHF) | Placebo | 5.97 | 95% Confidence Interval 5.37 to 6.62 | Patients with event /100 pt-yrs at risk | |
| Time to First Adjudicated Hospitalisation for Heart Failure (HHF) | 10 mg Empagliflozin | 4.28 | 95% Confidence Interval 3.78 to 4.82 | Patients with event /100 pt-yrs at risk |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 2,991 | |
| Overall Study | STARTED | 10 mg Empagliflozin | 2,997 | |
| Overall Study | Treated | Placebo | 2,989 | |
| Overall Study | Treated | 10 mg Empagliflozin | 2,996 | |
| Overall Study | COMPLETED | Placebo | 2,046 | |
| Overall Study | COMPLETED | 10 mg Empagliflozin | 2,051 | |
| Overall Study | NOT COMPLETED | Placebo | 945 | |
| Overall Study | NOT COMPLETED | 10 mg Empagliflozin | 946 |
Source ClinicalTrials.gov
Adverse events2,154
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 | Anaemia | Blood and lymphatic system disorders | Placebo | 164 | 2,989 | |
| other | Anaemia | Blood and lymphatic system disorders | 10 mg Empagliflozin | 119 | 2,996 | |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 156 | 2,989 | |
| other | Atrial fibrillation | Cardiac disorders | 10 mg Empagliflozin | 137 | 2,996 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 160 | 2,989 | |
| other | Urinary tract infection | Infections and infestations | 10 mg Empagliflozin | 207 | 2,996 | |
| other | Fall | Injury, poisoning and procedural complications | Placebo | 193 | 2,989 | |
| other | Fall | Injury, poisoning and procedural complications | 10 mg Empagliflozin | 189 | 2,996 | |
| other | Diabetes mellitus | Metabolism and nutrition disorders | Placebo | 200 | 2,989 | |
| other | Diabetes mellitus | Metabolism and nutrition disorders | 10 mg Empagliflozin | 139 | 2,996 |
1 to 10 of 2,154Source ClinicalTrials.gov
See all 2,154 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 427 | 2,991 |
| Total, all-cause mortality | 10 mg Empagliflozin | 422 | 2,997 |
| Total, other adverse events | Placebo | 1,274 | 2,989 |
| Total, other adverse events | 10 mg Empagliflozin | 1,191 | 2,996 |
| Total, serious adverse events | Placebo | 1,543 | 2,989 |
| Total, serious adverse events | 10 mg Empagliflozin | 1,436 | 2,996 |
Source ClinicalTrials.gov
Papers23
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/NCT03057951
GET https://conductscience.org/api/trials/v1/NCT03057951/events?page=2