Baseline characteristics of patients with heart failure with preserved ejection fraction in the EMPEROR‐Preserved trial

Abstract

Aims EMPEROR‐Preserved is an ongoing trial evaluating the effect of empagliflozin in patients with heart failure with preserved ejection fraction (HFpEF). This report describes the baseline characteristics of the EMPEROR‐Preserved cohort and compares them with patients enrolled in prior HFpEF trials. Methods and results EMPEROR‐Preserved is a phase III randomized, international, double‐blind, parallel‐group, placebo‐controlled trial in which 5988 symptomatic HFpEF patients [left ventricular ejection fraction (LVEF) >40%] with and without type 2 diabetes mellitus (T2DM) have been enrolled. Patients were required to have elevated N‐terminal pro B‐type natriuretic peptide (NT‐proBNP) concentrations (i.e. >300 pg/mL in patients without and >900 pg/mL in patients with atrial fibrillation) along with evidence of structural changes in the heart or documented history of heart failure hospitalization. Among patients enrolled from various regions (45% Europe, 11% Asia, 25% Latin America, 12% North America), the mean age was 72 ± 9 years, 45% were women. Almost all patients had New York Heart Association class II or III symptoms (99.6%), and 23% had prior heart failure hospitalization within 12 months. Thirty‐three percent of the patients had baseline LVEF of 41–50%. The mean LVEF (54 ± 9%) was slightly lower while the median NT‐proBNP [974 (499–1731) pg/mL] was higher compared with previous HFpEF trials. Presence of comorbidities such as diabetes (49%) and chronic kidney disease (50%) were common. The majority of the patients were on angiotensin‐converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor–neprilysin inhibitors (80%) and beta‐blockers (86%), and 37% of patients were on mineralocorticoid receptor antagonists. Conclusion When compared with prior trials in HFpEF, the EMPEROR‐Preserved cohort has a somewhat higher burden of comorbidities, lower LVEF, higher median NT‐proBNP and greater use of mineralocorticoid receptor antagonists at baseline. Results of the EMPEROR‐Preserved trial will be available in 2021.

Beta-Hydroxybutyrate, Friend or Foe for Stressed Hearts

“…Empagliflozin significantly improves cardiovascular and renal outcomes in patients independent of baseline diabetes status in the EMOEROR-Reduced trial (Packer et al, 2020) and significantly improves cardiac function and quality of life in HFrEF patients in the EMPA-TROPISM trial (Santos-Gallego et al, 2021). The clinical trial to investigate the effects of SGLT2i on HFpEF is still in progress (Anker et al, 2020).…”

Sodium-glucose Co-transporter 2 Inhibitors: a New Path for Heart Failure Treatment

“…There are 2 ongoing trials which designed to investigate the clinical effect of SGLT2i in HFpEF patients. The EMPEROR-Preserved trial enrolled 4,126 HFpEF patients to empagliflozin or placebo ( NCT03057951 ), 35) 36) and the DELIVER trial enrolled 4,700 patients to dapagliflozin or placebo ( NCT01297257 ); both clinical trials are expected to be completed and reported in 2021–2022.…”

A mechanistic rationale for the investigation of sodium–glucose co‐transporter 2 inhibitors in heart failure with preserved ejection fraction. Letter regarding the article ‘Baseline characteristics of patients with heart failure with preserved ejection fraction in the EMPEROR‐Preserved trial’

“…Recently in this Journal Anker et al published the trial design and baseline characteristics of the EMPEROR-Preserved trial. 1,2 Compared to previous heart failure with preserved ejection fraction (HFpEF) trials investigating established drugs for the treatment of heart failure with reduced ejection fraction (HFrEF), the mechanistic evidence of empagliflozin as a rationale for treating patients with HFpEF seems to be more promising. Accordingly, we believe that the first experimental findings in human HFrEF and HFpEF myocardium have to be taken into consideration in this elegant clinical trial as they pave the way for a deeper mechanistic understanding of the potential effects of empagliflozin in the EMPEROR-Preserved trial.…”