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

NCT07052071 | Recruiting

• 1 other identifier: GUT-TAVI
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis; Gut Microbiome; Gut Microbiota; TAVI; TAVI(Transcatheter Aortic Valve Implantation)

Keywords

TAVI

Outcome Measures

Primary Outcomes (1)

• Change in gut microbiota composition (via 16S rRNA sequencing)

  3 months post TAVI

Secondary Outcomes (3)

• Change in serum trimethylamine N-oxide (TMAO) levels

  3 months post TAVI

• Correlation of microbiota changes with severity of aortic stenosis at baseline

  3 months post TAVI

• Correlation of microbiota changes with haemodynamic parameters

  3 months post TAVI

Study Arms (1)

TAVI

Procedure: TAVI

Interventions

TAVI PROCEDURE

Transcatheter Aortic Valve Implantation (TAVI) is a minimally invasive method for replacing the aortic valve in patients with severe aortic stenosis. The procedure involves the placement of a bioprosthetic valve within the patient's degenerated aortic valve via a catheter.

TAVI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include 40 patients undergoing clinically indicated TAVI at the Hemodynamic Laboratory of the "Hippokration" General Hospital of Athens. This sample size is considered sufficient based on the limited available literature. Interim analysis will be conducted after the first 10 patients have completed the study to reassess and, if necessary, adjust the final sample size. Written informed consent is a prerequisite for inclusion.

You may qualify if:

• Aortic stenosis suitable for TAVI

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hippocration General Hospital: lead

Study Sites (1)

Hippokration General Hospital of Athens

Athens, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood (TMAO and other biochemical markers) without DNA analysis. Stool with DNA extraction for 16S rRNA sequencing.

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Konstantinos Tsioufis

CONTACT

+302132088099; grammateia@acardio-ekpa.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

GR (1)