EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure EMPEROR-Preserved
- Conditions
- Heart failure (HF) with preserved ejection fraction (EF).MedDRA version: 20.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2016-002278-11-IT
- Lead Sponsor
- BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4126
- 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,
OR
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms.;Secondary Objective: Not applicable;Primary end point(s): Time to first event of adjudicated CV death or adjudicated HHF in patients with Heart Failure with preserved Ejection Fraction (HFpEF).;Timepoint(s) of evaluation of this end point: Report time to event
- Secondary Outcome Measures
Name Time Method