| Outcome Measures: |
Primary: To show that treatment with balcinrenone preserves the beneficial dapagliflozin-driven increase in 24h renal glucose excretion, Change from baseline in 24h urine glucose excretion at day 28, 28 days | Secondary: To demonstrate that the dapagliflozin induced increase in urine solute concentration is not altered by balcinrenone, Change from baseline in urine osmolality at day 3 and day 28, 28 days|To demonstrate that treatment with dapagliflozin, with or without balcinrenone reduces free-water clearance within 48h, and further urine concentration is observed after 4 weeks, Change from baseline in free water clearance at day 3 and day 28, 28 days|To demonstrate that treatment with dapagliflozin, with or without balcinrenone, increases the contribution of glucose to osmoticdiuretic volume formation within 48h, and that this effect persists after 4 weeks, Change from baseline in urine glucose fraction at day 3 and day 28, 28 days|To demonstrate that treatment with dapagliflozin, with or without balcinrenone, decreases the contribution of sodium and urea to osmotic-diuretic volume formation within 48h, and that this effect persists after 4 weeks, Change from baseline in urine sodium fraction at day 3 and day 28; Change from baseline in urine urea fraction at day 3 and day 28, 28 days|To demonstrate that treatment with dapagliflozin, with or without balcinrenone, does not change the contribution of potassium to osmotic-diuretic volume formation within 48h, and that this effect persists after 4 weeks, Change from baseline in urine potassium fraction at day 3 and day 28, 28 days|To demonstrate that treatment with dapagliflozin with or without balcinrenone does not change body water content after 4 weeks, Change from baseline in muscle water content as measured at 7T MRI at day 28, 28 days|To demonstrate that patients treated with dapagliflozin alone or in combination with balcinrenone show increased plasma copeptin levels within 48h and/or after 4 weeks, Change from baseline in copeptin levels at day 3 and day 28, 28 days|To demonstrate that patients treated with dapagliflozin alone or in combination balcinrenone show increased plasma glucagon and reduced plasma insulin levels within 48h and/or after 4 weeks, Change from baseline in plasma insulin/glucagon ratio at day 3 and day 28, 28 days | Other: To demonstrate that treatment with dapagliflozin and/or balcinrenone for 4 weeks does not change tissue Na+ content as measured with MRI at 7T, Change from baseline in tissue Na+ content at day 28, 28 days|To demonstrate that treatment with dapagliflozin with or without balcinrenone will increase muscle nitrogen transfer and induce pH changes during the rest-exercise-recovery period, Change from baseline in pH levels levels at day 28 as quantified with 31P spectroscopy at 3T MRI, 28 days|To test the hypothesis that parallel to RAAS activation, patients treated with dapagliflozin show increased 24h urine cortisol excretion independent of parallel balcinrenone treatment, Change from baseline in 24h urine cortisol levels at day 3 and day 28, 28 days
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| Locations: |
Assistance Publique-Hopitaux de Marseille (AP-HM), Marseille, 13005, France|Klinikum Nuernberg, Nuremberg, Bavaria, 90419, Germany
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