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.
- Klíčová slova
- Empagliflozin, Heart failure with preserved ejection fraction, Sodium-glucose co-transporter 2 inhibitors,
- MeSH
- benzhydrylové sloučeniny terapeutické užití MeSH
- biologické markery krev MeSH
- diabetes mellitus 2. typu * farmakoterapie MeSH
- dvojitá slepá metoda MeSH
- glifloziny terapeutické užití MeSH
- glukosidy terapeutické užití MeSH
- kardiovaskulární látky terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- natriuretický peptid typu B krev MeSH
- peptidové fragmenty krev MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdeční selhání * krev diagnóza farmakoterapie patofyziologie MeSH
- tepový objem MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- benzhydrylové sloučeniny MeSH
- biologické markery MeSH
- empagliflozin MeSH Prohlížeč
- glifloziny MeSH
- glukosidy MeSH
- kardiovaskulární látky MeSH
- natriuretický peptid typu B MeSH
- peptidové fragmenty MeSH
- pro-brain natriuretic peptide (1-76) MeSH Prohlížeč