SGLT2 inhibitor with and without ALDosterone AntagonIst for heart failure with preserved ejection fraction: Design paper
Abstract
Background: Sodium glucose co-transporter 2 inhibitors (SGLT2i) and mineralocorticoid receptor antagonists (MRA) reduce heart failure (HF) events in patients with heart failure and mildly reduced or preserved ejection fraction (HFmr/pEF). The randomized comparison of SGLT2i/MRA combination versus SGLT2i or MRA alone requires further testing in HFmr/pEF.
Aims: 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).
Methods: 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.
Results: SOGALDI-PEF included 108 patients with a median age of 76 years,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 108 participants or records.
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