Dapagliflozin With or Without Spironolactone for HFpEF

Summary

Heart failure (HF) is a condition in which the heart does not contract ("pump") or relax well, leading to insufficient perfusion of vital organs. Ankle swelling, fatigue, and breathlessness are some of the features of this syndrome. There are different causes for HF (eg., infarct and hypertension) and two distinct types: HFrEF - HF with reduced ejection fraction - where the heart does not "pump" properly, and HFpEF - HF with preserved ejection fraction - the heart "pumps" but does not relax well. Treatment for HFrEF is better established than for HFpEF. In HFpEF, only mineralocorticoid receptors antagonists (MRAs) have been shown to reduce hospitalizations, circulating markers of cardiac dysfunction and fibrosis, and blood pressure. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are a therapeutic class that reduces morbidity and mortality in patients with high cardiovascular risk and diabetes and in patients with HFrEF with and without diabetes. Trials are underway to test whether SGLT2i may also be useful for the treatment of HFpEF. This work aims to compare the effects of SGLT2i alone and in combination in an MRA in patients with HFpEF.

Timeline

Start

2022-09-15

Primary completion

2024-11-29

Completion

2024-11-29

Publications

• Ferreira JP, Marques P, Neves JS, Leite AR, Teixeira C, Saraiva F, Sharma A, Zannad F, Pimenta J, Fontes-Carvalho R, Leite-Moreira A, Vasques-Novoa F; SOGALDI-PEF Investigators. Renin, Aldosterone, and Treatment Response to Dapagliflozin, Spironolactone, and Their Combination: An Analysis From SOGALDI-PEF. JACC Heart Fail. 2026 May 22:103111. doi: 10.1016/j.jchf.2026.103111. Online ahead of print.
• Ferreira JP, Vasques-Novoa F, Saraiva F, Oliveira AC, Almeida J, Batista AB, Barbosa A, Ferreira AF, Costa C, Diaz SO, Santos-Ferreira D, Frioes F, Goncalves C, Guimaraes JT, Leite M, Marques P, Mascarenhas J, Matos MI, Pereira C, Rodrigues P, Sharma A, Silva G, Pereira-Sousa I, Sousa C, Zannad F, Pimenta J, Fontes-Carvalho R, Leite-Moreira A. Sodium-Glucose Cotransporter 2 Inhibitor With and Without an Aldosterone Antagonist for Heart Failure With Preserved Ejection Fraction: The SOGALDI-PEF Trial. J Am Coll Cardiol. 2025 Aug 5;86(5):320-333. doi: 10.1016/j.jacc.2025.05.033.

Drugs

Indications