Heart failure & cardiomyopathies
SGLT2 Inhibitor with and without ALDosterone AntagonIst for Heart Failure with Preserved Ejection Fraction: Design Paper
Study context
- Population
- Patients with heart failure and mildly reduced or preserved ejection fraction (HFmr/pEF)patients included, sample size estimated to provide 80% power, at a 0.05 alfa level, to detect a 0.15 LogNT-proBNP difference
- Participants
- 108 patients
- Planned comparison
- Dapagliflozin/spironolactone combination versus dapagliflozin alone (primary comparison) and spironolactone alone (exploratory comparison)
- Primary endpoint
- NT-proBNP change
Methodological detailsdesign paper, three periods of 12 weeks each intercalated by a wash-out period of 4 weeks, mid-trial protocol amendment dropped the spironolactone alone sequence and reduced the wash-out period to 1 week
- Design paper
- Three periods of 12 weeks each intercalated by a wash-out period of 4 weeks
- Mid-trial protocol amendment dropped the spironolactone alone sequence and reduced the wash-out period to 1 week
No results yet. This paper sets out the design of a trial; its results are to come.
Baseline
Baseline characteristics
- Median age
- 76 years
- Women
- 57%
- Atrial fibrillation
- 42%
- Type 2 diabetes
- 46%
- eGFR below 60 mL/min/1.73m2
- 33%
- Ejection fraction ≥ 50%
- 93%
- Median serum potassium
- 4.3 mmol/L
- Median NT-proBNP
- 764 pg/mL
- Renin-angiotensin blockers
- 68%
- Beta-blockers
- 70%
- 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
Original publication
SGLT2 Inhibitor with and without ALDosterone AntagonIst for Heart Failure with Preserved Ejection Fraction: Design Paper. ESC Heart Fail. Published 19 May 2025. doi:10.
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