Phase 3
N=5,988
EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03057951 ↗Enrolled (actual)
5,988
Serious AEs
49.8%
Results posted
Jun 2022
Primary outcome: Primary: Time to First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) — 8.67; 6.86 Patients with event/100 pt-yrs at risk — p=0.0003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Empagliflozin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) |
8.67; 6.86 | 0.0003 sig |
| SECONDARY Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent) |
541; 407 | 0.0009 sig |
| SECONDARY eGFR (CKD-EPI) cr Slope of Change From Baseline |
-2.616; -1.253 | <0.0001 sig |
| SECONDARY Time to the First Event in the Composite Renal Endpoint: Chronic Dialysis, Renal Transplant, or Sustained Reduction in eGFR (CKD-EPI)cr |
2.23; 2.13 | 0.7243 |
| SECONDARY Time to First Adjudicated Hospitalisation for Heart Failure (HHF) |
5.97; 4.28 | <0.0001 sig |
| SECONDARY Time to Adjudicated Cardiovascular (CV) Death |
3.81; 3.42 | 0.2951 |
| SECONDARY Time to All-cause Mortality |
6.67; 6.60 | 0.9893 |
| SECONDARY Time to Onset of Diabetes Mellitus (DM) in Patients With Pre-DM |
7.39; 6.12 | 0.1539 |
| SECONDARY Change From Baseline in Kansas City Cardiomyopathy Questionaire (KCCQ) Clinical Summary Score at Week 52 |
3.18; 4.51 | 0.0028 sig |
| SECONDARY Occurrence of All-cause Hospitalisation (First and Recurrent) |
2769; 2566 | 0.1012 |
Summary
This is a study in adults with chronic heart failure. People with chronic heart failure may need to be hospitalised for their condition. Some people with chronic heart failure may eventually die from their condition. The purpose of the study is to find out whether a medicine called empagliflozin lowers the chances of patients having to go to hospital for heart failure and whether it improves their survival. The study is open to patients with a type of chronic heart failure called chronic heart failure with preserved ejection fraction.
Participants stay in the study until researchers have enough information about how effective empagliflozin is. It is expected that participants who enter at the very beginning of the enrolment period may be in the study for over 3 years, while participants who enter near the end of the enrolment period may be in the study for less than 2 years. The participants are put into 2 groups. It is decided by chance who gets into which group. One group gets empagliflozin tablets every day and the other group gets placebo tablets every day. Placebo tablets look like empagliflozin tablets but contain no medicine.
Participants visit the doctors regularly. During these visits, the doctors collect information about the participant's health. The doctors want to know how many patients had to go to hospital because of heart failure or who died from cardiovascular disease.
Eligibility Criteria
Inclusion criteria
- Male or female patient, age >= 18 years at screening. For Japan only: Age >=20 years at screening
- Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
- Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1
- Stable dose of oral diuretics, if prescribed
- Signed and dated written ICF (informed consent form)
- Further inclusion criteria apply
Exclusion criteria
- Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
- Heart transplant recipient or listed for heart transplant
- Acute decompensated HF (Heart Failure)
- Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
- Symptomatic hypotension and/or a SBP < 100 mmHg
- Indication of liver disease,
- Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr or requiring dialysis
- History of ketoacidosis
- Current use or prior use of a SGLT (Sodium-glucose co-transporter) -2 inhibitor or combined SGLT-1 and 2 inhibitor
- Currently enrolled in another investigational device or drug trial
- Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Further exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03057951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.