EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Heart Failure

Treatments

Drug: Empagliflozin

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03057951

1245.110

2016-002278-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

5,988 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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