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Heart surgery may reshape your gut microbiome

NCT ID NCT07052071

Knowledge-focused Sponsor: Hippocration General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether replacing a narrowed heart valve (TAVI) changes the types of bacteria living in the gut. Researchers will collect stool and blood samples from 40 patients before and after the procedure. The goal is to see if improved blood flow from the new valve helps restore a healthier gut microbiome, which could open new doors for heart disease treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcatheter Aortic Valve Implantation (TAVI) procedure
What this could lead to
If successful, this could reveal a connection between heart function and gut health, pointing toward new ways to treat cardiovascular disease by targeting the microbiome.
What could go wrong
This is a small, early observational study with only 40 participants. It looks at changes in gut bacteria, not direct treatment outcomes, so results may not lead to immediate medical advances.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis Gut microbiome Gut microbiota TAVI Tavi(transcatheter aortic valve implantation)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hippokration General Hospital of Athens

    RECRUITING

    Athens, Greece

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