Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for people with aortic stenosis (a narrowed heart valve) who can have TAVI, a valve replacement through a tube. It studies gut bacteria before and after the procedure.

Nem

All sexes can join.

A betegség stádiuma

Aortic stenosis that can be treated with TAVI. The summary describes it as severe.

Korábbi kezelés

People cannot join if they used antibiotics, systemic corticosteroids, antivirals, probiotics, bile acid sequestrants or new medicines within one month before joining.

A részvétel fő kizáró okai

• Inflammatory bowel disease in the past, or a current acute infection.
• End-stage kidney disease needing dialysis, or end-stage chronic liver disease.
• Aortic stenosis caused by rheumatic fever or infectious endocarditis (a heart valve infection).
• Active cancer under treatment.
• Mental illness that affects the ability to consent, or drug or alcohol abuse.

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

This study investigates the impact of transcatheter aortic valve implantation (TAVI) on the composition and function of the gut microbiota in patients with severe aortic valve stenosis. The improvement in haemodynamics following TAVI may positively influence gut microbial balance by increasing splanchnic perfusion and reducing intestinal congestion. A total of 40 patients undergoing TAVI at the "Hippokration" General Hospital of Athens will be enrolled, with the aim of analysing stool and blood samples before and after the procedure. The primary endpoint is the change in gut microbiota composition two months post-TAVI, assessed via 16S rRNA sequencing. Secondary endpoints include changes in serum TMAO levels and their association with the severity of aortic stenosis and post-procedural valve haemodynamics. Data will be collected at two timepoints (1 month up to 1 day pre-TAVI and 3 to 4 months post-TAVI), along with dietary questionnaires to account for potential confounding factors. This observational study aims to highlight the potential relationship between cardiac function and the gut microbiome, offering new perspectives for targeted therapeutic strategies in cardiovascular disease.

A vizsgálat csoportja

• TAVI