How TAVI affects gut bacteria in people with severe aortic stenosis
Official title: Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis
Run by Hippocration General Hospital · NCT07052071 · Data updated 2026-11-12
This will test whether transcatheter aortic valve implantation (TAVI) changes the gut microbiota and related blood markers in people with severe aortic stenosis.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Hippocration General Hospital Academic / other |
| Locations | 1 site (Athens) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | September 1, 2027 |
| Study ends | November 1, 2027 |
| Registry record updated | November 18, 2025 |
| Trial ID | NCT07052071 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with severe aortic stenosis who are scheduled for TAVI and who have not taken antibiotics, probiotics, systemic steroids, or similar medications in the month before enrollment.
✕Probably not a fit
Patients with recent antibiotic or probiotic use, inflammatory bowel disease, end‑stage liver or kidney disease, active infection, or ongoing cancer treatment are unlikely to benefit or be eligible for this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will enroll 40 patients undergoing TAVI at Hippokration General Hospital in Athens and collect stool and blood samples before and several months after the procedure. Gut microbiota composition will be measured by 16S rRNA sequencing with the primary endpoint set at roughly two months post‑TAVI, and serum TMAO will be measured as a secondary marker. Clinical, echocardiographic and dietary questionnaire data will be collected to link haemodynamic changes and potential confounders to microbiome shifts. The design is longitudinal within-patient comparison rather than randomized or interventional.
Why it matters
Potential benefit: If successful, the study could show that restoring valve function with TAVI favorably alters gut microbiota and metabolic markers, suggesting a reversible link between haemodynamics and intestinal ecology.
How similar studies have gone: Cardiac dysfunction has been associated with gut microbiome changes in prior research, but few studies have specifically examined microbiome shifts after TAVI, so this approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aortic stenosis suitable for TAVI Exclusion Criteria: Patients will be excluded if they present any condition or intervention that may independently affect gut microbiota composition. These include: * 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. Patients with aortic stenosis due to rheumatic fever or infectious endocarditis will be excluded. * Active cancer under treatment. * Psychiatric illness impairing ability to consent. * Substance or alcohol abuse.
Where it's running
-
Hippokration General Hospital of Athens
Athens, Greece Recruiting
Study contacts
- Study coordinator: Konstantinos Tsioufis
- Email: grammateia@acardio-ekpa.gr
- Phone: +302132088099
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.