A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF). - EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure EMPEROR-Preserved

BOEHRINGER INGELHEIM INTERNATIONAL GMBH0 个研究点目标入组 4,126 人开始时间: 2021年6月3日最近更新: 2021年6月7日

适应症

试验速览

暂无简介。

•- Patients with chronic HF diagnosed for at least 3 months before Visit 1 and currently in HF New York Heart Association (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 N-terminal of the prohormone brain natriuretic peptide (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:
•a) Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) documented by echocardiogram at Visit 1,
•b) Documented hospitalisation for HF (HHF) within 12 months prior to Visit 1
•- Oral diuretics, if prescribed to patient according to local guideline and discretion of the Investigator, should be stable for at least 1 week prior to Visit 2 (Randomisation)
•- eGFR (CKD-EPI)cr = 20 mL/min/1.73m2 at Visit 1
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 2063
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2063

•1. Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA in past 90 days prior to Visit 1
•2. Heart transplant recipient or listed for heart transplant
•3. Implantation of cardioverter defibrillator (ICD) within 3 months prior to Visit 1
•4. Implanted cardiac resynchronisation therapy (CRT)
•5. Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic
•obstructive cardiomyopathy or known pericardial constriction
•6. Any severe valvular heart disease expected to lead to
•surgery during the trial in the Investigator’s opinion
•7. Acute decompensated 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)
•8. Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm documented by ECG at Visit 2 (Randomisation)
•9. 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
•10. Symptomatic hypotension and/or a SBP < 100 mmHg at Visit 1 or Visit 2

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