18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)Primary· 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 pat
Group
Value
95% CI
Placebo
21.00
19.13 – 22.96
10 mg Empagliflozin
15.77
14.19 – 17.44
Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)Secondary· 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.
Group
Value
95% CI
Placebo
553
10 mg Empagliflozin
388
eGFR (CKD-EPI) cr Slope of Change From BaselineSecondary· 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.
Group
Value
95% CI
Placebo
-2.278
± 0.229
10 mg Empagliflozin
-0.546
± 0.227
Time to First Event in Composite Renal Endpoint: Chronic Dialysis, Renal Transplant or Sustained Reduction of eGFR(CKD-EPI)crSecondary· 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
Group
Value
95% CI
Placebo
3.07
2.33 – 3.91
10 mg Empagliflozin
1.56
1.06 – 2.17
Time to First Adjudicated Hospitalisation for Heart Failure (HHF)Secondary· 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.
Group
Value
95% CI
Placebo
15.55
13.94 – 17.24
10 mg Empagliflozin
10.75
9.45 – 12.13
Time to Adjudicated Cardiovascular (CV) DeathSecondary· 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
Group
Value
95% CI
Placebo
8.13
7.05 – 9.29
10 mg Empagliflozin
7.55
6.51 – 8.67
Time to All-cause MortalitySecondary· 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-ye
Group
Value
95% CI
Placebo
10.71
9.46 – 12.04
10 mg Empagliflozin
10.06
8.85 – 11.34
Time to Onset of Diabetes Mellitus (DM)Secondary· 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 censo
Group
Value
95% CI
Placebo
10.62
8.42 – 13.07
10 mg Empagliflozin
9.31
7.27 – 11.60
Change From Baseline in KCCQ (Kansas City Cardiomyopathy Questionnaire) Clinical Summary Score at Week 52Secondary· 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 indicatin
Group
Value
95% CI
Placebo
-3.36
± 0.69
10 mg Empagliflozin
-1.30
± 0.69
Number of All-cause Hospitalizations (First and Recurrent)Secondary· From randomisation until completion of the planned treatment phase, up to 1040 days.
Number of all-cause hospitalizations (first and recurrent).
Group
Value
95% CI
Placebo
1570
10 mg Empagliflozin
1364
Adverse events — posted to ClinicalTrials.gov
Time frame: From first intake of study medication until end of planned treatment period + 7 days (Residual Effect Period), up to 1047 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07060417 — Vascular Effects of SGLT2i in Non-diabetic CKD
· Phase 2
· not yet recruiting
NCT06625073 — Randomized Trial of SGLT2i in Heart Transplant Recipients
· Phase 4
· recruiting
NCT07107945 — A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease
· Phase 3
· recruiting
NCT07214818 — SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome
· Phase 2, PHASE3
· active not recruiting
NCT07180745 — Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease
· Phase 4
· not yet recruiting
Other recruiting trials for Heart Failure
Currently open trials in the same condition.
NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF)
· NA
· recruiting
NCT07496372 — Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart
· Phase 3
· recruiting
NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure
· Phase 4
· recruiting
NCT07531966 — Vascular Complications After Kidney Transplantation
· recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection
· not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a
· not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I
· Phase 3
· not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants
· Phase 1
· not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
· Phase 3
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 18 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03057977.