chronic Heart Failure with preserved Ejection Fraction
Conditions
Interventions
* 4-21 days screening period
* Approximately 20-38 months double-blind treatment until the required number
of adjudicated primary events is reached with empagliflozin or placebo
* Follow-up visit 3
Efficacy
Empagliflozin
Heart failure
Safety
Sponsors
Boehringer Ingelheim International GmbH
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * 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. A historical LVEF may be used if it was measured within 6 months prior to visit 1, and more than 90 days after any myocardial infarction (as defined in exclusion criterion No.1) or the LVEF may be measured after study consent has been obtained. The LVEF must be documented in an official report prior to randomization. * 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 - 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
Exclusion criteria
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 Screening * Systolic blood pressure (SBP) * 180 mmHg at Visit 2. If SBP >150 mmHg and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite primary endpoint for this trial is the time to first event of adjudicated CV death or adjudicated HHF in patients with HFpEF. | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary endpoints which are part of the testing strategy, are the following: - Occurrence of adjudicated HHF (first and recurrent) - eGFR (CKD-EPI)cr slope of change from baseline Other secondary endpoints are: - Time to first occurrence of chronic dialysis or renal transplant or sustained reduction of *40% eGFR (CKD-EPI)cr or a sustained eGFR (CKD-EPI)cr | — |
Countries
The Netherlands
Outcome results
None listed