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The randomized comparison of SGLT2i\/MRA combination versus SGLT2i or MRA alone requires further testing in HFmr\/pEF.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To compare the efficacy (NT-proBNP change as primary outcome) and safety (potassium, creatinine, and blood pressure changes) of dapagliflozin\/spironolactone combination versus dapagliflozin alone (primary comparison) and spironolactone alone (exploratory comparison).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>SOGALDI-PEF (SOdium-Glucose cotransporter 2 inhibitor, ALDosterone AntagonIst, or both for heart failure with preserved ejection fraction; NCT05676684), a proof-of-concept investigator-initiated two-centre randomized cross-over trial comparing three arms (dapagliflozin, spironolactone, or both) for three periods of 12 weeks each intercalated by a wash-out period of 4 weeks. After two independent trials demonstrating efficacy of SGLT2i in HFmr\/pEF, a mid-trial protocol amendment dropped the spironolactone alone sequence and reduced the wash-out period to 1 week. A sample size of 108 patients was estimated to provide 80% power, at a 0.05 alfa level, to detect a 0.15 LogNT-proBNP difference between the spironolactone\/dapagliflozin combination and dapagliflozin alone sequence.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>SOGALDI-PEF included 108 patients with a median age of 76 years, 57% women, 42% with atrial fibrillation, 46% with type 2 diabetes, 33% having an eGFR below 60 mL\/min\/1.73m2, and 93% having an ejection fraction \u2265 50%. The median serum potassium was 4.3 mmol\/L, and the median NT-proBNP was 764 pg\/mL. Most patients were treated with renin\u2013angiotensin blockers (68%), beta-blockers (70%) and loop diuretics (69%). Compared to other HFmr\/pEF trials, SOGALDI-PEF patients were older, were more frequently women, had a high prevalence of atrial fibrillation, and had more often a preserved ejection fraction.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>SOGALDI-PEF will be the first trial in HFmr\/pEF to test the combination of dapagliflozin\/spironolactone vs dapagliflozin alone in a randomized manner. SOGALDI-PEF will provide information on the potential efficacy and safety of concomitant administration of spironolactone with dapagliflozin vs dapagliflozin alone in an elderly population with HFmr\/pEF.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ehf2.15294","type":"journal-article","created":{"date-parts":[[2025,5,19]],"date-time":"2025-05-19T12:41:42Z","timestamp":1747658502000},"page":"3134-3144","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["SGLT2 Inhibitor with and without ALDosterone AntagonIst for Heart Failure with Preserved Ejection Fraction: Design Paper"],"prefix":"10.1093","volume":"12","author":[{"given":"Jo\u00e3o Pedro","family":"Ferreira","sequence":"first","affiliation":[{"name":"RISE-Health, Departamento de Cirurgia e Fisiologia, Faculdade de Medicina, Universidade do Porto , Porto ,","place":["Portugal"]},{"name":"Universit\u00e9 de Lorraine INSERM, Centre d'Investigations 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