Overview

Dapagliflozin, Spironolactone or Both for HFpEF

Status:
Recruiting
Trial end date:
2024-12-15
Target enrollment:
Participant gender:
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 MRAs and SGLT2i alone, plus their combination in patients with HFpEF.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Universidade do Porto
Collaborators:
Centro Hospitalar De São João, E.P.E. (CHUSJ)
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Treatments:
Dapagliflozin
Spironolactone