Effect of Dapagliflozin on myocardial and renal function following aortic valve stenosis intervention

Aortic stenosis

Changes from baseline to 12 months of follow-up in at least 2 out of 4 well-known parameters of performance in AS is required to reach the primary endpoint. The level of change, in percentage points (%P), is considered clinically significant based on existing litterature: • LVMi reduction of 10 % point (by CMRI) • LV GLS absolute increase of 2.0 % point (by TTE) • A decrease in serum Nt-proBNP of more than 25% • Relative increase of 10% in eGFR

1. Difference in the change in eGFR from baseline to 12-months, 2. Difference in eGFR at 12-months., 3. The number of patients with a relative difference of 10 % of myocardial interstitial fibrosis evaluated by the biomarker extracellular volume (ECV) by late enhancement gadolinium by CMR, 4. The number of patients with a >10% decrease in cardiac fibrosis when assessed by CMR using native T1-mapping., 5. Composite endpoint of worsening HF with hospitalization or urgent outpatient clinical visit due to HF, and all-cause mortality, 6. All-cause mortality, 7. Worsening HF with hospitalization or urgent outpatient clinical visit due to HF, 8. Difference in the change in urinary albumin/creatinine ratio (ACR) from baseline to 12-months., 9. Difference in ACR at 12-months., 10. 24-hour ambulatory blood pressure changes from baseline to 12 months., 11. Change from baseline to 12-months follow-up in the KCCQ Total Symptom Score, 12. Change from baseline to 12-months follow-up in NYHA-class, 13. LVMi reduction of 10 % point (by CMRI) from baseline to 12-months follow-up, 14. LV GLS absolute increase of 2.0 % point (by TTE) from baseline to 12-months follow-up, 15. A decrease in serum Nt-proBNP of more than 25% from baseline to 12-months follow-up, 16. Relative increase of 10% in eGFR measured at baseline and 12-months

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