Rationale and design of the EMPERIAL-Preserved and EMPERIAL-Reduced trials of empagliflozin in patients with chronic heart failure.
Adult
Benzhydryl Compounds
/ administration & dosage
Diabetes Mellitus, Type 2
/ complications
Double-Blind Method
Drug Monitoring
/ methods
Exercise Tolerance
/ drug effects
Female
Glucosides
/ administration & dosage
Heart Failure
/ complications
Humans
Male
Patient Reported Outcome Measures
Physical Functional Performance
Quality of Life
Randomized Controlled Trials as Topic
Sodium-Glucose Transporter 2 Inhibitors
/ administration & dosage
Stroke Volume
Empagliflozin
Exercise capacity
Heart failure
Sodium-glucose co-transporter 2 inhibitor
Journal
European journal of heart failure
ISSN: 1879-0844
Titre abrégé: Eur J Heart Fail
Pays: England
ID NLM: 100887595
Informations de publication
Date de publication:
07 2019
07 2019
Historique:
received:
14
12
2018
revised:
10
04
2019
accepted:
11
04
2019
pubmed:
21
6
2019
medline:
3
10
2020
entrez:
21
6
2019
Statut:
ppublish
Résumé
Heart failure (HF) is associated with considerable symptom burden and impairment in physical functioning and quality of life. The sodium-glucose co-transporter 2 inhibitor empagliflozin reduced the risk of HF hospitalisation and cardiovascular death in patients with type 2 diabetes and established cardiovascular disease in the EMPA-REG OUTCOME trial, and could potentially improve congestion symptoms and exercise capacity in patients with HF. We describe the designs of the EMPERIAL-Preserved and EMPERIAL-Reduced trials of empagliflozin in patients with chronic stable HF, with or without type 2 diabetes. EMPERIAL-Preserved and EMPERIAL-Reduced are randomised, placebo-controlled trials designed to investigate the effects of empagliflozin on exercise capacity and patient-reported outcomes in patients with chronic stable HF with preserved ejection fraction [HFpEF; left ventricular ejection fraction (LVEF) > 40%] and HF with reduced ejection fraction (HFrEF; LVEF ≤ 40%), respectively. In each trial, approximately 300 patients will be randomised 1:1 to receive empagliflozin 10 mg or placebo once daily for 12 weeks. In both trials, the primary endpoint is the change from baseline in 6-min walk test distance at week 12. Key secondary endpoints are the change from baseline in Kansas City Cardiomyopathy Questionnaire total symptom score and change from baseline in dyspnoea score of the Chronic Heart Failure Questionnaire at week 12. The EMPERIAL-Preserved and EMPERIAL-Reduced trials will determine the effects of empagliflozin on exercise capacity and patient-reported outcomes in patients with HFpEF and HFrEF, respectively, and provide insight into the potential of empagliflozin in the treatment of patients with HF. ClinicalTrials.gov ID: NCT03448406 (EMPERIAL-Preserved), NCT03448419 (EMPERIAL-Reduced).
Identifiants
pubmed: 31218819
doi: 10.1002/ejhf.1486
pmc: PMC6774309
doi:
Substances chimiques
Benzhydryl Compounds
0
Glucosides
0
Sodium-Glucose Transporter 2 Inhibitors
0
empagliflozin
HDC1R2M35U
Banques de données
ClinicalTrials.gov
['NCT03448406', 'NCT03448419']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
932-942Investigateurs
William Abraham
(W)
Stefan Anker
(S)
JoAnn Lindenfeld
(J)
Piotr Ponikowski
(P)
Martina Brueckmann
(M)
Afshin Salsali
(A)
Francine Welty
(F)
Tim Clayton
(T)
Barry Greenberg
(B)
Marvin Konstam
(M)
Kennedy Lees
(K)
Mike Palmer
(M)
Klaus Parhofer
(K)
Terje Pedersen
(T)
Peter Carson
(P)
James Freston
(J)
Neil Kaplowitz
(N)
James Lewis
(J)
Johannes Mann
(J)
John Petrie
(J)
Piergiuseppe Agostoni
(P)
Javed Butler
(J)
Akshay Desai
(A)
Gerasimos Filippatos
(G)
Jonathan Howlett
(J)
Jerzy Wranicz
(J)
Josep Redón Mas
(JR)
José Silva Cardoso
(JS)
Stefan Störk
(S)
Informations de copyright
© 2019 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
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