EMPEROR-Preserved
INCLUSION Criteria
- Age ≥ 18 years at screening
- Male or female patients.
- Patients with chronic HF diagnosed for at least 3 months before Visit 1, and currently in HF NYHA class II-IV
- Chronic HF with preserved EF defined as LVEF > 40 % per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, MRI or CT), and no prior measurement of LVEF ≤ 40% under stable conditions. The EF must have been obtained and documented at Visit 1 or within 6 months prior to Visit 1, and more than 90 days after any myocardial infarction.
- Elevated NT-proBNP > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1.
- Patients must have at least one of the following evidence of HF:
- Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) documented by echocardiogram at Visit 1 or within 6 months prior to Visit 1, OR
- Documented HHF within 12 months prior to Visit 1
- Oral diuretics, if prescribed to patient according to local guidelines and discretion of the Investigator, should be stable for at least 1 week prior to Visit 2 (Randomisation).
- Body Mass Index (BMI) < 45 kg/m2 at Visit 1
- Signed and dated written ICF in accordance with GCP and local legislation prior to admission to the trial.
EXCLUSION Criteria
- Myocardial infarction (increase in cardiac enzymes in combination with symptoms of ischaemia or newly developed ischaemic ECG changes), coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA in past 90 days prior to Visit 1.
- Heart transplant recipient or listed for heart transplant
- Implantation of cardioverter defibrillator (ICD) within 3 months prior to Visit 1
- Implanted cardiac resynchronisation therapy (CRT)
- Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction.
- Any severe (obstructive or regurgitant) valvular heart disease expected to lead to surgery during the trial in the Investigator’s opinion
- Acute decompensated HF (exacerbation of chronic HF) requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 1 week from discharge to Visit 1, and during screening period until Visit 2 (Randomisation).
- Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm documented by ECG at Visit 2 (Randomisation).
- Systolic blood pressure (SBP) ≥ 180 mmHg at Visit 2. If SBP >150 mmHg and <180 mmHg at Visit 2, the patient should be receiving at least 3 antihypertensive drugs.
- Symptomatic hypotension and/or a SBP < 100 mmHg at Visit 1 or Visit 2
- Chronic pulmonary disease requiring home oxygen, oral steroid therapy on hospitalisation for exacerbation within 12 months, or significant chronic pulmonary disease in the Investigator’s opinion, or primary pulmonary arterial hypertension.
- Indication of liver disease, defined by serum levels of either ALT (SGPT), AST(SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at V.1
- Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis, as determined at Visit 1
- Haemoglobin < 9 g/dl at Visit 1
- History of ketoacidosis
- Major surgery (major according to the investigator’s assessment) performed within 90 days prior to Visit 1, or scheduled major elective surgery (e.g. hip replacement ) within 90 days after visit 1
- Gastrointestinal (GI) surgery or GI disorder that could interfere with absorption of trial medication in the investigator’s opinion.
- Any documented active or suspected malignancy or history of malignancy within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix or low risk prostate cancer (patients with pretreatment PSA < 10 ng/mL and biopsy Gleason score of ≤ 6 and clinical stage T1c or T2a).
- Presence of any other disease than heart failure with a life expectancy of <1 year in the investigator’s opinion.
- Patients who must or wish to continue the intake of restricted medications
- Treatment with any SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor within 1 week prior to Visit 1 or during screening period until Visit 2 (Randomisation)
- Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s). Patients participating in a purely observational trial will not be excluded.
- Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
- Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, makes them an unreliable trial subject or unlikely to complete the trial
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Any other clinical condition that would jeopardise patients safety while participating in this trial, or may prevent the subject from adhering to the trial protocol
Ansprechpartner
Dederer,
Juliane
Fachärztin für Innere Medizin und Angiologie
06841 - 16 - 15000
Prof. Dr. med.
Kindermann,
Ingrid
Leiterin HFU-/Spezial-Ambulanz, Studienzentrum, Oberärztin Station 8 (WLS)
Ansprechpartner im Studienzentrum
Neurath,
Barbara
Leitung Studienambulanz (Geb. 24)
Dr.
Wachter,
Angelika
Stellv. Leitung Studienzentrum (Geb. 24)
