EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
Purpose
The aim of the study is to evaluate efficacy and safety of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with preserved ejection fraction
Condition
- Heart Failure
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Empagliflozin |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Audie L. Murphy VA Hospital
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- NCT ID
- NCT03057951
- Status
- Recruiting
- Sponsor
- Boehringer Ingelheim
Study Contact
Boehringer Ingelheim Call Center1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com