September 16, 2019Open Access
View Full PaperEvaluation of the Effects of Sodium–Glucose Co-Transporter 2 Inhibition with Empagliflozin on Morbidity and Mortality in Patients with Chronic Heart Failure and a Preserved Ejection Fraction: Rationale for and Design of the EMPEROR-Preserved Trial
Structured PICO
Does empagliflozin reduce the combined risk for cardiovascular death or hospitalization for heart failure in patients with chronic heart failure and a preserved ejection fraction?
P
Population
Patients with chronic heart failure and a preserved ejection fraction (HFpEF)
I
Intervention
Empagliflozin
O
Outcome
Time-to-first-event analysis of the combined risk for cardiovascular death or hospitalization for heart failurecomposite
This paper outlines the rationale and design for the EMPEROR-Preserved trial, which aims to evaluate the efficacy of empagliflozin in patients with HFpEF.
Abstract
The primary endpoint is the time-to-first-event analysis of the combined risk for cardiovascular death or hospitalization for heart failure. The trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death, all-cause mortality and recurrent hospitalization events, and will assess a wide range of biomarkers that reflect important pathophysiological mechanisms that may drive the evolution of HFpEF. The EMPEROR-Preserved Trial is well positioned to determine if empagliflozin can have a meaningful impact on the course of HFpEF, a disorder for which there are currently few therapeutic options.