Effect on Clinical Status, Structural and Functional Cardiac Parameters and Myocardial Fibrosis of Triple Combination Therapy With a Sodium-glucose Cotransporter 2 Inhibitor, Angiotensin Receptor/Neprilysin Inhibitor and Mineralocorticoid Receptor Antagonist in Patients With Advanced HFpEF
Patients with advanced heart failure with preserved ejection fraction (HFpEF) will be randomly assigned in open-label multicenter study to receive triple combination therapy with \[angiotensin receptor/neprilysin inhibitor \[ARNI\] + sodium-glucose cotransporter 2 inhibitor \[SGLTi\] + mineralocorticoid receptor antagonist \[MRA\]) or with individualized medical therapy \[SGLTi + renin-angiotensin system inhibitor \[RASi\] \[angiotensin receptor blocker \[ARB\] or angiotensin-converting enzyme inhibitor \[ACE-I\]), and will be treated for 52 weeks
⁃ Signed and data informed consent;
⁃ Symptoms and signs of HF;
⁃ LV ejection fraction \> 50%;
⁃ NT-proBNP \> 300 pg/mL (for patients with atrial fibrillation NT-proBNP \> 900 pg/mL)
⁃ LV diastolic dysfunction II-III grade OR
‣ LV diastolic dysfunction I grade and at least 2 out of 4:
• Е/е' \> 14
• LAVi \> 34 ml/m2 (for those with persistent atrial fibrillation \> 40 ml/m2)
• PASP \> 35 mm Hg or TR velocity \> 2.8 m/sec
• LV mass index \> 95 g/m2 for women / \> 115 g/m2 for men or LV interventricular septum or posterior wall thickness ≥ 1.1 sm OR
‣ Chronic atrial fibrillation and at least 3 out of 4:
• Е/е' \> 11
• E-wave velocity \> 100 sm/s
• TR velocity \> 2.8 sm/s
• DT ≤ 160 ms