Clinical Trial

Impact of TAVI on the Gut Microbiota and Its Metabolites

Study acronym: Swiss-GUT-TAVI
Active, Not Recruiting
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Summary
Aortic stenosis is a common heart valve disease in older adults. It occurs when the aortic valve becomes narrowed, making it harder for blood to flow from the heart to the rest of the body. Without treatment, this condition can lead to serious complications and reduced survival. A widely used treatment is transcatheter aortic valve implantation (TAVI), a minimally invasive procedure that replaces the diseased valve and improves blood flow. Recent research suggests that heart diseases, including aortic stenosis, may affect the gut (intestinal) environment. The gut contains trillions of microorganisms (called the gut microbiota) that play an important role in digestion, immunity, and overall health. In patients with heart conditions, reduced blood flow may impair the intestinal barrier and alter the balance of these microorganisms. This imbalance may contribute to inflammation and other complications. This study aims to better understand how aortic stenosis and its treatment with TAVI influence the gut microbiota and intestinal health. Researchers will measure specific substances produced by gut bacteria (called metabolites) in blood and stool samples. These include bile acids, trimethylamine N-oxide (TMAO), tryptophan-related compounds, and short-chain fatty acids. Samples will be collected before and three months after the TAVI procedure. In addition, genetic analysis of stool samples will be performed to identify and compare the types of bacteria present before and after treatment. The goal is to determine whether improving heart function with TAVI can restore a healthier gut environment. This may help identify new ways to improve outcomes and reduce complications in patients with aortic stenosis.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-27.
Trial Details
NCT Number NCT07565077
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Collaborators: Tours university
Conditions Calcific Aortic Valve Disease, Inflammation, Dysbiosis, TAVI
Enrollment 40 participants
Start Date 2024-03-01
Primary Completion 2026-02-28 (estimated)
Study Completion 2029-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-05-08