Effects of Empagliflozin on Exercise Capacity and Left Ventricular Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction and Type-2 Diabetes Mellitus

Inclusion Criteria

• •1. Males and females aged 45 to 80 years at screening
• •2. Diagnosis of type-2 diabetes mellitus with stable glucose-lowering background therapy for at least 12 weeks
• •3. HbA1c ≥ 6,5% and ≤ 10% at screening
• •4. Diagnosis of HFpEF which includes:
• •* Symptoms ± signs (as defined in 2016 European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure)
• •* Ejection fraction ≥ 50% (by Simpson)
• •* Increased LV filling pressures at rest or during exercise determined by echocardiography (LV diastolic dysfunction grade II/III and/or positive diastolic stress test) \[according to American Society of Echocardiography and European Association of Cardiovascular Imaging (ASE/EACVI) Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography, 2016\]
• •5. Signed and dated informed consent