Impact of Transcatheter Aortic Valve Implantation on the Composition and Function of the Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in gut microbiota-derived metabolite levels before and after TAVI
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •- 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.
研究组 & 干预措施
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.
结局指标
主要结局
Change in gut microbiota-derived metabolite levels before and after TAVI
时间窗: 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).
次要结局
- Change in gut microbiota diversity after TAVI(Baseline and 3 months post-TAVI)
- Change in gut microbiota taxonomic composition after TAVI(Baseline and 3 months post-TAVI)
- Sex-specific differences in gut microbiota changes following TAVI(Baseline and 3 months post-TAVI)
- Association between gut microbiota changes and systemic biomarkers(Baseline and 3 months post-TAVI)
- Prognostic value of gut microbiota and metabolite changes after TAVI(From baseline to 3 months post-TAVI (and clinical follow-up, if applicable))