SOGALDI-PEF: SGLT2 inhibitor plus MRA improves outcomes in HFp/mrEF

The combination of dapagliflozin and spironolactone resulted in improvements in NT-proBNP, eGFR, and serum potassium outcomes, compared with dapagliflozin alone, in patients with heart failure with preserved or mildly reduced ejection fraction (HFp/mrEF).

The SOGALDI-PEF trial (EudraCT 2020-000973-26) compared the safety and efficacy of the combination of the sodium-glucose cotransporter-2 (SGLT2) inhibitor dapagliflozin and the mineralocorticoid receptor antagonist (MRA) spironolactone with that of dapagliflozin alone in 108 patients with HFp/mrEF [1]. The primary outcome of this prospective, randomised trial was NT-proBNP level at 12 weeks.

The combination therapy was associated with a larger reduction in logNT-proBNP than the monotherapy (Δ-0.11; 95% CI -0.22 to -0.01; P=0.035). Furthermore, participants in the combination therapy arm displayed larger reductions in systolic blood pressure (Δ-6.4 mmHg; 95% CI -8.3 to -4.4; P<0.001) and eGFR, as well as a more pronounced increase in serum potassium. These were secondary efficacy outcomes of the trial. “We did see a higher rate of systolic blood pressure <100 mmHg (8.6% vs 3.8%) and serum potassium >5.5 mmol/L (4.8% vs 0.9%) in the combination arm,” Dr Joao Ferreira (University of Porto, Portugal) addressed the adverse events in the study. However, the study sample was small and was not powered to evaluate safety outcomes.

In summary, patients with HFp/mrEF on dapagliflozin plus spironolactone showed better outcomes regarding NT-proBNP, eGFR, and serum potassium than those on dapagliflozin monotherapy.

1. Ferreira JP, et al. Sodium glucose cotransporter 2 inhibitor with and without an aldosterone antagonist for heart failure with preserved ejection fraction: SOGALDI-PEF. Hottest trials and trial updates (1), Heart Failure 2025, 17–20 May, Belgrade, Serbia.

Medical writing support was provided by Robert van den Heuvel.
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Posted on 20 May 202517 July 2025