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Clinical Trial Will Assess Profile of Gut Microbiome in Heart Failure Patients

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Researchers at Oslo University Hospital say a clinical study called the GutHeart Trial is set to examine the potential relationship between the gut microbiome and inflammatory and metabolic pathways in the cardiovascular system. The Phase II randomized controlled trial will enroll patients with heart failure who will receive an antibiotic, a probiotic yeast, or no treatment on top of recommended heart failure treatment.

The team described their study (“Design of the GutHeart—targeting gut microbiota to treat heart failure—trial: a Phase II, randomized clinical trial”) in ESC Heart Failure.

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,” write the investigators.

“GutHeart is a randomized, open-label, controlled trial. Four centers 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 three months. The primary endpoint is baseline-adjusted left ventricular ejection fraction as measured by echocardiography after three months. A further follow-up six months after randomization will be undertaken.

“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.”

"To the best of our knowledge, the GutHeart trial is the first intervention study to assess the profile of the gut microbiota in heart failure patients and the way this profile is affected by drugs that act locally in the gut," says first author Cristiane C. K. Mayerhofer, M.D., of Oslo University Hospital, in Norway. "The new knowledge can pave the way for new innovative treatment strategies and will lead to a better understanding of how gut leakage is associated with inflammatory processes and heart failure."

The potential significance of the study extends beyond the cardiovascular system, notes co-author Ayodeji Awoyemi, M.D., research fellow, Oslo University Hospital. "It will most definitely expand our knowledge with regard to the clinical implications of modulating the gut microbiome," he says.

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