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

Change in left ventricular mass index (LVMI)

Difference in LVMI assessed by echocardiography between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change in left atrial volume index (LAVI)

Difference in LAVI assessed by echocardiography between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change in left atrial stiffness

Difference in left atrial stiffness assessed as a ratio of mitral E/e' ratio to left atrial strain s between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change estimated pulmonary artery systolic pressure (PASP)

Difference in PASP assessed by echocardiography both at rest and during diastolic stress test (DST) between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change in average e' velocity

Difference in average e' velocity assessed by echocardiography both at rest and during diastolic stress test (DST) between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change in average E/e' ratio

Difference in average E/e' ratio assessed by echocardiography both at rest and during diastolic stress between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change in N-terminal pro b-type natriuretic peptide (NT-proBNP)

Difference in NT-proBNP plasma levels between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change in Cyclic guanosine monophosphate (cGMP)

Difference in cGMP plasma levels between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change in Endothelin 1 (ET-1)

Difference in ET-1 plasma levels between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change in Growth/differentiation factor 15 (GDF-15)

Difference in GDF-15 plasma levels between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change in ST2

Difference in ST2 plasma levels between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change in Galectin-3

Difference in Galectin-3 plasma levels between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change in carboxyterminal propeptide of type I collagen (PICP)

Difference in PICP plasma levels between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change in Human Pentraxin 3 (PTX3)

Difference in PTX3 plasma levels between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change in high-sensitivity C-reactive protein (hsCRP)

Difference in hsCRP plasma levels between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change in Interleukin-6 (IL-6)

Difference in IL-6 plasma levels between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change of New York Heart Association (NYHA) functional classification

Difference in NYHA class between 24 weeks after baseline and at baseline

Time frame: 24 weeks

Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) score

Difference in MLHFQ score between 24 weeks after baseline and at baseline. The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses. Score ranges from 0 (best quality of life) to 105 (worst quality of life).

Time frame: 24 weeks