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dc.contributor.authorMayerhofer, Christiane Caroline
dc.contributor.authorAwoyemi, Ayodeji Olawale
dc.contributor.authorMoscavitch, Samuel D.
dc.contributor.authorLappegård, Knut Tore
dc.contributor.authorHov, Johannes Espolin Roksund
dc.contributor.authorAukrust, Pål
dc.contributor.authorHovland, Anders
dc.contributor.authorLorenzo, Andrea
dc.contributor.authorHalvorsen, Sigrun
dc.contributor.authorSeljeflot, Ingebjørg
dc.contributor.authorGullestad, Lars
dc.contributor.authorTrøseid, Marius
dc.contributor.authorBroch, Kaspar
dc.date.accessioned2018-10-31T12:21:48Z
dc.date.available2018-10-31T12:21:48Z
dc.date.issued2018-08-07
dc.description.abstract<p><i>Aims</i>: Heart failure (HF) is a multifactorial disease. Current treatments target only a fraction of the putative pathophysiological pathways. In patients with HF, reduced cardiac output and congestion cause increased gut wall permeability. It has been suggested that leakage of microbial products is detrimental to the heart, at least partly through activation of systemic inflammatory pathways, which again could promote gut leakage. Whether manipulating the gut microbiota can improve cardiac function in patients with HF remains unknown. We aim to evaluate the effect of drugs targeting the gut microbiota on left ventricular function, quality of life, and functional capacity, as well as on markers of gut leakage and inflammation, in stable patients with HF with reduced ejection fraction.</p> <p><i>Methods and results</i>: GutHeart is a randomized, open‐label, controlled trial. Four centres will randomize 150 patients with stable HF and a left ventricular ejection fraction <40% to receive the antibiotic rifaximin, the probiotic yeast <i>Saccharomyces boulardii</i> (ATCC 74012), or no treatment (control) in a 1:1:1 fashion. Treatment will last for 3 months. The primary endpoint is baseline‐adjusted left ventricular ejection fraction as measured by echocardiography after 3 months. A further follow‐up 6 months after randomization will be undertaken.</p> <p><i>Conclusions</i>: This trial is likely to give new insights into important disease processes involving the gut microbiota in HF patients, hereby leading to new potential therapeutic strategies to prevent and down‐regulate the inflammation seen in these patients.</p>en_US
dc.description.sponsorshipNorwegian Health Association Stein Erik Hagen's Foundation for Clinical Heart Researchen_US
dc.descriptionSource at <a href=https://doi.org/10.1002/ehf2.12332> https://doi.org/10.1002/ehf2.12332</a>. Licensed <a href=http://creativecommons.org/licenses/by-nc-nd/4.0/> CC BY-NC-ND 4.0.</a>en_US
dc.identifier.citationMayerhofer, C.C.K., Awoyemi, A.O., Moscavitch, S.D., Lappegård, K.T., Hov, J.R., Aukrust, P., ... Broch, K. (2018). Design of the GutHeart-targeting gut microbiota to treat heart failure-trial: a Phase II, randomized clinical trial. ESC Heart Failure, 5, 978-985. https://doi.org/10.1002/ehf2.12332en_US
dc.identifier.cristinIDFRIDAID 1618772
dc.identifier.doi10.1002/ehf2.12332
dc.identifier.issn2055-5822
dc.identifier.urihttps://hdl.handle.net/10037/14069
dc.language.isoengen_US
dc.publisherWiley Open Accessen_US
dc.relation.journalESC Heart Failure
dc.rights.accessRightsopenAccessen_US
dc.subjectHeart failureen_US
dc.subjectGut microbiotaen_US
dc.subjectRemodellingen_US
dc.subjectRandomized controlled trialen_US
dc.subjectStudy designen_US
dc.subjectMicrobial translocationen_US
dc.subjectVDP::Medical disciplines: 700::Clinical medical disciplines: 750::Cardiology: 771en_US
dc.subjectVDP::Medisinske Fag: 700::Klinisk medisinske fag: 750::Kardiologi: 771en_US
dc.titleDesign of the GutHeart—targeting gut microbiota to treat heart failure—trial: a Phase II, randomized clinical trialen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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