NCT05676684: SOGALDI-PEF

Dapagliflozin With or Without Spironolactone for HFpEF

Completed Phase 2, PHASE3 Last updated 17 August 2025

What this trial tests

Phase 2, PHASE3 trial testing Dapagliflozin in Heart Failure With Preserved Ejection Fraction in 108 participants. Completed in 29 November 2024.

Timeline

15 September 2022

Primary endpoint
29 November 2024

29 November 2024

Quick facts

Lead sponsor	Universidade do Porto
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	108
Start date	15 September 2022
Primary completion	29 November 2024
Estimated completion	29 November 2024
Sites	2 locations across Portugal

Drugs / interventions tested

• Dapagliflozin (DAPAGLIFLOZIN) — full drug profile →
• Spironolactone + Dapagliflozin — full drug profile →

Conditions studied

• Heart Failure With Preserved Ejection Fraction — all drugs for Heart Failure With Preserved Ejection Fraction →

Sponsor

Universidade do Porto — full company profile →

Who can join

50 and older, any sex, with Heart Failure With Preserved Ejection Fraction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction (SPIRRIT-HFpEF): Rationale and design.
   Lund LH, James S, DeVore AD, Anstrom KJ, et al · · 2024 · cited 21× · PMID 39282788 · DOI 10.1002/ejhf.3453
2. Sodium-Glucose Cotransporter 2 Inhibitor With and Without an Aldosterone Antagonist for Heart Failure With Preserved Ejection Fraction: The SOGALDI-PEF Trial.
   Ferreira JP, Vasques-Nóvoa F, Saraiva F, Oliveira AC, et al · · 2025 · cited 12× · PMID 40738559 · DOI 10.1016/j.jacc.2025.05.033
3. SGLT2 inhibitor with and without ALDosterone AntagonIst for heart failure with preserved ejection fraction: Design paper.
   Ferreira JP, Vasques-Nóvoa F, Saraiva F, Oliveira AC, et al · · 2025 · cited 3× · PMID 40388563 · DOI 10.1002/ehf2.15294
4. Renin, Aldosterone, and Treatment Response to Dapagliflozin, Spironolactone, and Their Combination: An Analysis From SOGALDI-PEF.
   Ferreira JP, Marques P, Neves JS, Leite AR, et al · · 2026 · PMID 42201301 · DOI 10.1016/j.jchf.2026.103111
5. Mineralocorticoid receptor antagonists for the treatment of heart failure and kidney disease: a state-of-the-art review.
   Van Spall HGC, Vardeny O. · · 2026 · PMID 42189342 · DOI 10.1007/s10741-026-10636-0
6. Cardiovascular pharmacotherapy in 2025.
   Tamargo J, Agewall S, Ambrosio G, Borghi C, et al · · 2026 · PMID 41935384 · DOI 10.1093/ehjcvp/pvag016