NCT05676684

Dapagliflozin With or Without Spironolactone for HFpEF

SOdium-Glucose Cotransporter 2 Inhibitor With and Without an ALDosterone AntagonIst for Heart Failure With Preserved Ejection Fraction: a Two-centre Randomised Crossover Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Universidade do Porto · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
DRUG	Dapagliflozin	A: Dapagliflozin 10 mg once daily
DRUG	Spironolactone + Dapagliflozin	C: Dapagliflozin 10 mg once daily plus Spironolactone 25mg/every other day or 25mg/day (can be adjusted according to potassium and renal function)

Timeline

• Start date: 2022-09-15
• Primary completion: 2024-11-29
• Completion: 2024-11-29
• First posted: 2023-01-09
• Last updated: 2025-08-17

Locations

2 sites across 1 country: Portugal