Researchers are currently conducting a trial to assess the effects of manipulating the gut microbiota in patients with HF, according to a paper published in ESC Heart Failure.
“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,” Cristiane C.K. Mayerhofer, MD, of Oslo University Hospital and University of Oslo in Norway, said in a press release. “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.”
Through this phase 2, open-label, randomized controlled trial, researchers will address whether the gut microbiota potentially activates inflammation, which may play a role in HF by inducing metabolic disturbances, according to the paper. The trial will be conducted at three centers in Norway and one in Brazil.
Patients included in the trial have stable, symptomatic HF and are not likely to improve with recommended treatment. Those included were required to have at least 3 months of optimal pharmacological treatment for HF and, if indicated, at least 6 months of cardiac resynchronization therapy.
Patients were excluded if they had concomitant diseases that would affect the gut microbiota, have taken antibiotic treatment within the past 3 months or were taking either over-the-counter probiotic substances or probiotic drugs on a regular basis.
Study-specific procedures included echocardiography, clinical examination, quality-of-life questionnaire, 6-minute walk test, blood sampling, food frequency questionnaire and measurements such as height and weight. Fecal samples will also be taken at baseline, 3 and 6 months.
Patients were assigned to treatment with Saccharomyces boulardii, rifaximin (Xifaxan, Salix Pharmaceuticals) or control in addition to regular HF treatment.
The primary endpoint is baseline-adjusted left ventricular ejection fraction at 3 months. Secondary endpoints include microbiota-related metabolites, gut microbiota composition, cardiac function parameters beyond LVEF, health-related quality of life, inflammatory and anti-inflammatory mediators, endothelial function, functional capacity and safety.
“Potentially, our results will provide the rationale for new therapeutic strategies in patients with HF,” Mayerhofer and colleagues wrote. “The findings could also be of relevance for other disorders where there may be interactions between gut microbiota on the one hand and inflammation and metabolic pathways on the other. Such disorders include atherosclerosis and related metabolic disorders (eg, obesity, diabetes and liver steatosis) as well as autoimmune and autoinflammatory diseases.” – by Darlene Dobkowski
Disclosures: The authors report no relevant financial disclosures.