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dc.contributor.authorHundertmark, Moritz J
dc.contributor.authorAgbaje, Olorunsola F
dc.contributor.authorColeman, Ruth
dc.contributor.authorGeorge, Jyothis T
dc.contributor.authorGrempler, Rolf
dc.contributor.authorHolman, Rury R
dc.contributor.authorLamlum, Hanan
dc.contributor.authorLee, Jisoo
dc.contributor.authorMilton, Joanne E
dc.contributor.authorNiessen, Heiko G
dc.contributor.authorRider, Oliver
dc.contributor.authorRodgers, Christopher T
dc.contributor.authorValkovič, Ladislav
dc.contributor.authorWicks, Eleanor
dc.contributor.authorMahmod, Masliza
dc.contributor.authorNeubauer, Stefan
dc.date.accessioned2021-05-05T23:30:33Z
dc.date.available2021-05-05T23:30:33Z
dc.date.issued2021-08
dc.identifier.issn2055-5822
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/322013
dc.description.abstractAIMS: Despite substantial improvements over the last three decades, heart failure (HF) remains associated with a poor prognosis. The sodium-glucose co-transporter-2 inhibitor empagliflozin demonstrated significant reductions of HF hospitalization in patients with HF independent of the presence or absence of type 2 diabetes mellitus in the EMPEROR-Reduced trial and cardiovascular mortality in the EMPA-REG OUTCOME trial. To further elucidate the mechanisms behind these positive outcomes, this study aims to determine the effects of empagliflozin treatment on cardiac energy metabolism and physiology using magnetic resonance spectroscopy (MRS) and cardiovascular magnetic resonance (CMR). METHODS AND RESULTS: The EMPA-VISION trial is a double-blind, randomized, placebo-controlled, mechanistic study. A maximum of 86 patients with HF with reduced ejection fraction (n = 43, Cohort A) or preserved ejection fraction (n = 43, Cohort B), with or without type 2 diabetes mellitus, will be enrolled. Participants will be randomized 1:1 to receive either 10 mg of empagliflozin or placebo for 12 weeks. Eligible patients will undergo cardiovascular magnetic resonance, resting and dobutamine stress MRS, echocardiograms, cardiopulmonary exercise tests, serum metabolomics, and quality of life questionnaires at baseline and after 12 weeks. The primary endpoint will be the change in resting phosphocreatine-to-adenosine triphosphate ratio, as measured by 31 Phosphorus-MRS. CONCLUSIONS: EMPA-VISION is the first clinical trial assessing the effects of empagliflozin treatment on cardiac energy metabolism in human subjects in vivo. The results will shed light on the mechanistic action of empagliflozin in patients with HF and help to explain the results of the safety and efficacy outcome trials (EMPEROR-Reduced and EMPEROR-Preserved).
dc.description.sponsorshipBoehringer Ingelheim is the sponsor of the EMPA-VISION study and was involved in its study design. Boehringer Ingelheim also supported the preparation of this article. S.N. acknowledges support from the Oxford British Heart Foundation (BHF) Centre of Research Excellence. R.R.H. and S.N. were supported by the Oxford National Institute for Health Research (NIHR) Biomedical Research Centre (BRC). C.T.R. is funded by a Sir Henry Dale Fellowship from the Wellcome Trust and the Royal Society [098436/Z/12/B]. L.V. gratefully acknowledges support of the Slovak Grant Agencies VEGA [2/0001/17] and APVV [#15–0029].
dc.format.mediumPrint-Electronic
dc.languageeng
dc.publisherWiley
dc.rightsAll rights reserved
dc.titleDesign and rationale of the EMPA-VISION trial: investigating the metabolic effects of empagliflozin in patients with heart failure.
dc.typeArticle
prism.endingPage2590
prism.issueIdentifier4
prism.publicationDate2021
prism.publicationNameESC Heart Fail
prism.startingPage2580
prism.volume8
dc.identifier.doi10.17863/CAM.69471
dcterms.dateAccepted2021-04-22
rioxxterms.versionofrecord10.1002/ehf2.13406
rioxxterms.versionAM
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2021-08
dc.contributor.orcidRodgers, Christopher [0000-0003-1275-1197]
dc.identifier.eissn2055-5822
rioxxterms.typeJournal Article/Review
pubs.funder-project-idWellcome Trust (Unknown)
pubs.funder-project-idWellcome Trust (098436/Z/12/B)
cam.issuedOnline2021-05-06
cam.orpheus.successTue Feb 01 19:01:13 GMT 2022 - Embargo updated
rioxxterms.freetoread.startdate2021-05-06


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