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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHippocration General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Aortic stenosis suitable for TAVI

Disqualifiers

Use of antibiotics, systemic corticosteroids, antivirals, probiotics, bile acid sequestrants, or new medications within one month prior to enrollment.

History of inflammatory bowel disease.

End-stage renal disease requiring dialysis.

End-stage chronic liver disease.

Trial design

Treatments tested in this trial

  • TAVI

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators