NCT07052071 Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis
| NCT ID | NCT07052071 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hippocration General Hospital |
| Condition | Aortic Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-09-01 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07052071 clinical trial?
This trial is open to participants of all sexes, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07052071 currently recruiting?
Yes, NCT07052071 is actively recruiting participants. Contact the research team at grammateia@acardio-ekpa.gr for enrollment information.
Where is the NCT07052071 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT07052071 clinical trial?
NCT07052071 is sponsored by Hippocration General Hospital. The trial plans to enroll 40 participants.