Impact of TAVI on the Gut Microbiota and Its Metabolites (Swiss-GUT-TAVI)
4 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Tipo di studio
Osservativo
Iscrizione (Effettivo)
40
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Bern, Svizzera, 3010
- Inselspital, Department of Cardiology
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in gut microbiota-derived metabolite levels before and after TAVI
Lasso di tempo: Baseline (pre-TAVI) and 3 months post-TAVI
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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).
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Baseline (pre-TAVI) and 3 months post-TAVI
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in gut microbiota diversity after TAVI
Lasso di tempo: Baseline and 3 months post-TAVI
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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.
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Baseline and 3 months post-TAVI
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Change in gut microbiota taxonomic composition after TAVI
Lasso di tempo: Baseline and 3 months post-TAVI
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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.
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Baseline and 3 months post-TAVI
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Sex-specific differences in gut microbiota changes following TAVI
Lasso di tempo: Baseline and 3 months post-TAVI
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Comparison of gut microbiota diversity (Shannon Index score) and composition (relative abundance percentage (%)) between male and female patients before and after TAVI.
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Baseline and 3 months post-TAVI
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Association between gut microbiota changes and systemic biomarkers
Lasso di tempo: Baseline and 3 months post-TAVI
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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).
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Baseline and 3 months post-TAVI
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Prognostic value of gut microbiota and metabolite changes after TAVI
Lasso di tempo: From baseline to 3 months post-TAVI (and clinical follow-up, if applicable)
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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.
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From baseline to 3 months post-TAVI (and clinical follow-up, if applicable)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Rajamannan NM. Calcific aortic stenosis: lessons learned from experimental and clinical studies. Arterioscler Thromb Vasc Biol. 2009 Feb;29(2):162-8. doi: 10.1161/ATVBAHA.107.156752. Epub 2008 Nov 20.
- Liao Y, Liu C, Xiong T, Zhao M, Zheng W, Feng Y, Li Y, Ou Y, Zhao Z, Peng Y, Wei J, Li Q, Meng W, Liu X, Chen M. Metabolic Modulation and Potential Biomarkers of the Prognosis Identification for Severe Aortic Stenosis after TAVR by a Metabolomics Study. Cardiol Res Pract. 2020 Oct 28;2020:3946913. doi: 10.1155/2020/3946913. eCollection 2020.
- Li J, Zeng Q, Xiong Z, Xian G, Liu Z, Zhan Q, Lai W, Ao L, Meng X, Ren H, Xu D. Trimethylamine N-oxide induces osteogenic responses in human aortic valve interstitial cells in vitro and aggravates aortic valve lesions in mice. Cardiovasc Res. 2022 Jun 29;118(8):2018-2030. doi: 10.1093/cvr/cvab243.
- Candellier A, Issa N, Grissi M, Brouette T, Avondo C, Gomila C, Blot G, Gubler B, Touati G, Bennis Y, Caus T, Brazier M, Choukroun G, Tribouilloy C, Kamel S, Boudot C, Henaut L; Stop-As Investigators. Indoxyl-sulfate activation of the AhR- NF-kappaB pathway promotes interleukin-6 secretion and the subsequent osteogenic differentiation of human valvular interstitial cells from the aortic valve. J Mol Cell Cardiol. 2023 Jun;179:18-29. doi: 10.1016/j.yjmcc.2023.03.011. Epub 2023 Mar 24.
- Chong Nguyen C, Duboc D, Rainteau D, Sokol H, Humbert L, Seksik P, Bellino A, Abdoul H, Bouazza N, Treluyer JM, Saadi M, Wahbi K, Soliman H, Coffin B, Bado A, Le Gall M, Varenne O, Duboc H. Circulating bile acids concentration is predictive of coronary artery disease in human. Sci Rep. 2021 Nov 22;11(1):22661. doi: 10.1038/s41598-021-02144-y.
- Chong-Nguyen C, Yilmaz B, Coles B, Sokol H, MacPherson A, Siepe M, Reineke D, Mosbahi S, Tomii D, Nakase M, Atighetchi S, Ferro C, Wingert C, Grani C, Pilgrim T, Windecker S, Blasco H, Dupuy C, Emond P, Banz Y, Losmanova T, Doring Y, Siontis GCM. A scoping review evaluating the current state of gut microbiota and its metabolites in valvular heart disease physiopathology. Eur J Clin Invest. 2025 Jun;55(6):e14381. doi: 10.1111/eci.14381. Epub 2025 Jan 10.
- Chong-Nguyen C, Fuentes Artiles R, Pilgrim T, Yilmaz B, Doring Y. The gut-heart axis in coronary artery disease: a scoping and narrative review of sex-based microbial and metabolic disparities. Biol Sex Differ. 2026 Jan 30;17(1):24. doi: 10.1186/s13293-026-00824-w.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 marzo 2024
Completamento primario (Effettivo)
28 febbraio 2026
Completamento dello studio (Stimato)
28 febbraio 2029
Date di iscrizione allo studio
Primo inviato
27 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
27 aprile 2026
Primo Inserito (Effettivo)
4 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2023-02339
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .