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Impact of TAVI on the Gut Microbiota and Its Metabolites (Swiss-GUT-TAVI)

4. maj 2026 opdateret af: Insel Gruppe AG, University Hospital Bern

Impact of Transcatheter Aortic Valve Implantation on the Composition and Function of the Gut Microbiota

Aortic stenosis is a common heart valve disease in older adults. It occurs when the aortic valve becomes narrowed, making it harder for blood to flow from the heart to the rest of the body. Without treatment, this condition can lead to serious complications and reduced survival. A widely used treatment is transcatheter aortic valve implantation (TAVI), a minimally invasive procedure that replaces the diseased valve and improves blood flow.

Recent research suggests that heart diseases, including aortic stenosis, may affect the gut (intestinal) environment. The gut contains trillions of microorganisms (called the gut microbiota) that play an important role in digestion, immunity, and overall health. In patients with heart conditions, reduced blood flow may impair the intestinal barrier and alter the balance of these microorganisms. This imbalance may contribute to inflammation and other complications.

This study aims to better understand how aortic stenosis and its treatment with TAVI influence the gut microbiota and intestinal health. Researchers will measure specific substances produced by gut bacteria (called metabolites) in blood and stool samples. These include bile acids, trimethylamine N-oxide (TMAO), tryptophan-related compounds, and short-chain fatty acids.

Samples will be collected before and three months after the TAVI procedure. In addition, genetic analysis of stool samples will be performed to identify and compare the types of bacteria present before and after treatment.

The goal is to determine whether improving heart function with TAVI can restore a healthier gut environment. This may help identify new ways to improve outcomes and reduce complications in patients with aortic stenosis.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

40

Kontakter og lokationer

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Studiesteder

  • Schweiz
      • Bern, Schweiz, 3010
        • Inselspital, Department of Cardiology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Patients with aortic stenosis undergoing TAVI
Patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) as part of routine clinical care. Assessments of gut microbiota composition and metabolomic profiles are performed before the procedure and at 3-month follow-up.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in gut microbiota-derived metabolite levels before and after TAVI
Tidsramme: Baseline (pre-TAVI) and 3 months post-TAVI
Quantitative assessment of key gut microbiota-derived metabolites-including bile acids (cholic, chenodeoxycholic, deoxycholic, and lithocholic acid measured via LC-MS in µmol/L), trimethylamine N-oxide (TMAO measured via LC-MS in µmol/L), tryptophan metabolites (measured via LC-MS in µmol/L), and short-chain fatty acids (SCFAs measured via GC-MS in µmol/g) in blood and stool samples, measured before and after transcatheter aortic valve implantation (TAVI).
Baseline (pre-TAVI) and 3 months post-TAVI

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in gut microbiota diversity after TAVI
Tidsramme: Baseline and 3 months post-TAVI
Assessment of gut microbiota diversity using 16S rRNA sequencing, including alpha diversity (measured by Shannon and Simpson indices on a scale of 0-10) and beta diversity (measured by Bray-Curtis dissimilarity index score from 0-1), in stool samples collected before and after TAVI.
Baseline and 3 months post-TAVI
Change in gut microbiota taxonomic composition after TAVI
Tidsramme: Baseline and 3 months post-TAVI
Analysis of the relative abundance (measured as a percentage of total sequences (%)) and distribution of bacterial families in stool microbiota using 16S rRNA sequencing before and after TAVI.
Baseline and 3 months post-TAVI
Sex-specific differences in gut microbiota changes following TAVI
Tidsramme: Baseline and 3 months post-TAVI
Comparison of gut microbiota diversity (Shannon Index score) and composition (relative abundance percentage (%)) between male and female patients before and after TAVI.
Baseline and 3 months post-TAVI
Association between gut microbiota changes and systemic biomarkers
Tidsramme: Baseline and 3 months post-TAVI
Evaluation of the statistical correlation (Pearson or Spearman coefficient r) between changes in gut microbiota composition (relative abundance %) and metabolite levels (µmol/L) with systemic markers of inflammation (including IL-6, IL-10, and TNF-α concentration in pg/mL measured via the Meso Scale Discovery [MSD] electrochemiluminescence platform), and cardiovascular function (NT-proBNP in pg/mL).
Baseline and 3 months post-TAVI
Prognostic value of gut microbiota and metabolite changes after TAVI
Tidsramme: From baseline to 3 months post-TAVI (and clinical follow-up, if applicable)
Assessment of the statistical correlation (Hazard Ratio or Correlation Coefficient r) between changes in gut microbiota composition (relative abundance %) and metabolite levels (µmol/L) with clinical outcomes, including incidence of heart failure, hemolysis, mortality, and prosthetic valve dysfunction.
From baseline to 3 months post-TAVI (and clinical follow-up, if applicable)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Insel Gruppe AG, University Hospital Bern

Samarbejdspartnere

Tours university

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2024

Primær færdiggørelse (Faktiske)

28. februar 2026

Studieafslutning (Anslået)

28. februar 2029

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2023-02339

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UBESLUTET

IPD-planbeskrivelse

The plan for sharing individual participant data is currently under evaluation. Data sharing will be considered in compliance with institutional guidelines, ethical approvals, and applicable data protection regulations.

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