Design of the GutHeart—targeting gut microbiota to treat heart failure trial: a Phase II, randomized clinical trial

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dc.contributor.authorMayerhofer, Cristiane C.K.
dc.contributor.authorAwoyemi, Ayodeji O
dc.contributor.authorMoscavitch, Samuel D.
dc.contributor.authorLappegård, Knut Tore
dc.contributor.authorHov, Johannes R.
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.accessioned2022-09-13T13:42:25Z
dc.date.available2022-09-13T13:42:25Z
dc.date.issued2018
dc.description.abstractAims 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. Methods and results 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 Saccharomyces boulardii (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. Conclusions 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.
dc.identifier.citationMayerhofer CCK, Awoyemi AO, Moscavitch SD, Lappegård KT, Hov JR, Aukrust P, Hovland A, Lorenzo A, Halvorsen S, Seljeflot I, Gullestad L, Trøseid M, Broch K. Design of the GutHeart—targeting gut microbiota to treat heart failure—trial: a Phase II, randomized clinical trial. ESC Heart Failure. 2018;5(5): 977-984.
dc.identifier.doiDOI: 10.1002/ehf2.12332
dc.identifier.urihttps://dspace.inc.saude.gov.br/handle/123456789/254
dc.language.isoen
dc.publisherESC Heart Failure
dc.subjectHeart failureen
dc.subjectGut microbiotaen
dc.subjectRemodellingen
dc.subjectRandomized controlled trialen
dc.subjectStudy designen
dc.subjectMicrobial translocationen
dc.subject.meshVentricular Function, Left / physiologyen
dc.subject.meshStroke Volume / physiologyen
dc.subject.meshSaccharomyces boulardiien
dc.subject.meshRandomized Controlled Trials as Topic / methodsen
dc.subject.meshHumansen
dc.subject.meshHeart Failure / therapyen
dc.subject.meshHeart Failure / physiopathologyen
dc.subject.meshGastrointestinal Microbiomeen
dc.subject.meshClinical Trials, Phase II as Topic / methodsen
dc.titleDesign of the GutHeart—targeting gut microbiota to treat heart failure trial: a Phase II, randomized clinical trialen
dc.typeArticle
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