Actively Recruiting
Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis
Led by Hippocration General Hospital · Updated on 2025-11-18
40
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with aortic stenosis suitable for transcatheter aortic valve implantation (TAVI)
You will not qualify if you...
- 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
- Acute infection or aortic stenosis caused by rheumatic fever or infectious endocarditis
- Active cancer under treatment
- Psychiatric illness impairing ability to consent
- Substance or alcohol abuse
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hippokration General Hospital of Athens
Athens, Greece
Actively Recruiting
Research Team
K
Konstantinos Tsioufis
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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