Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis
Launched by HIPPOCRATION GENERAL HOSPITAL · Jun 26, 2025
Trial Information
Current as of July 21, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how a heart valve procedure called Transcatheter Aortic Valve Implantation (TAVI) affects the community of bacteria living in the gut, known as the gut microbiota, in patients with a condition called aortic valve stenosis. Aortic stenosis means the heart’s aortic valve is narrowed, which can affect blood flow. The researchers want to see if improving heart function with TAVI also helps restore a healthy balance of gut bacteria by improving blood flow to the intestines. They will collect stool and blood samples from about 40 patients before and a few months after the procedure to examine any changes.
People who have severe aortic valve stenosis and are suitable candidates for TAVI may be eligible to join the study. However, patients who have conditions or treatments that could affect gut bacteria—like recent use of antibiotics, serious bowel diseases, advanced kidney or liver disease, infections, active cancer, or substance abuse—will not be included. If you participate, you can expect to provide stool and blood samples at three different times: before the TAVI procedure and a few months afterward. The study also includes simple questionnaires about your diet to help understand other factors that might influence gut bacteria. This research hopes to reveal new connections between heart health and gut bacteria, which could lead to better treatments in the future.
Gender
ALL
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.
About Hippocration General Hospital
Hippocration General Hospital is a renowned healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a commitment to high ethical standards and rigorous scientific methodology, the hospital collaborates with leading researchers and healthcare professionals to explore new treatments and therapies across various medical fields. By fostering a patient-centered approach and leveraging state-of-the-art facilities, Hippocration General Hospital aims to contribute significantly to the global body of medical knowledge and enhance the quality of care provided to its community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Athens, , Greece
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported