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Heart fix may heal your gut, new study hints

NCT ID NCT07565077

Knowledge-focused Sponsor: Insel Gruppe AG, University Hospital Bern Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how a common heart valve procedure called TAVI changes the gut microbiome in older adults with aortic stenosis. Researchers will collect blood and stool samples before and three months after TAVI to measure bacterial byproducts and diversity. The goal is to see if improving heart function can restore a healthier gut environment, which might reduce inflammation and complications. 40 participants are enrolled at a Swiss hospital.

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

40 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Feb 2029

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

Adult patients with severe aortic valve disease referred for transcatheter aortic valve implantation (TAVI) at a single tertiary care center. Patients are enrolled prospectively and undergo evaluation of gut microbiota composition and metabolomic profiles before and after TAVI.

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: * • 18 years or older * Hospitalized for TAVI or investigations before TAVI for significant aortic valve disease * Severe CAS is defined as: high flow gradient with normal CO (mean gradient ≥40mmHg, Vmax≥4m/s, valve area ≤ 1cm² or ≤0,6cm/m²) or low flow low gradient (mean gradient\<40mmHg, Vmax \<4m/s, valve area ≤ 1cm² or ≤0,6cm/m², stroke volume \< 35ml/m², LVEF\<40%) confirmed by low dose dobutamine echo or high calcium score (\> 1200 in women and \> 2000 in men), paradoxical low-gradient CAS: LVEF \> 55%, Vmax\< 4m/s, mean gradient \< 40mmHg, area \< 1cm²) * Combined aortic stenosis and aortic regurgitation, considered as severe valvular heart disease with a need for TAVI. * Written informed consent Exclusion Criteria: * \- Treatment interfering with the composition of the intestinal microbiota: local or systemic corticosteroids within the last 3 months, antibiotics within the last 3 months, antiretrovirals, bile acid chelators (questran and colesevelam), HIV-targeted antiretroviral therapies, selective serotonin reuptake inhibitor-type antidepressants * Clinical criteria: history of cholecystectomy, documented chronic liver disease in the patient, failure to fast on the day of the blood test, inflammatory bowel disease * Valve in valve TAVI. * LVEF \< 20% * Patients requiring emergency intervention (myocardial infarction, acute aortic or mitral regurgitation, cardiogenic shock). * AS of rheumatic origin, infective endocarditis.

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Conditions

The condition(s) this trial relates to.

aortic valve calcification Dysbiosis Inflammation inflammatory disease

As listed by the trial registrant

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

Calcific aortic valve disease Dysbiosis Inflammation TAVI

Contacts and locations

Locations

  • Inselspital, Department of Cardiology

    Bern, 3010, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.