Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in gut microbiota composition (via 16S rRNA sequencing)
研究概览
简要总结
This study investigates the impact of transcatheter aortic valve implantation (TAVI) on the composition and function of the gut microbiota in patients with severe aortic valve stenosis. The improvement in haemodynamics following TAVI may positively influence gut microbial balance by increasing splanchnic perfusion and reducing intestinal congestion. A total of 40 patients undergoing TAVI at the "Hippokration" General Hospital of Athens will be enrolled, with the aim of analysing stool and blood samples before and after the procedure. The primary endpoint is the change in gut microbiota composition two months post-TAVI, assessed via 16S rRNA sequencing. Secondary endpoints include changes in serum TMAO levels and their association with the severity of aortic stenosis and post-procedural valve haemodynamics. Data will be collected at two timepoints (1 month up to 1 day pre-TAVI and 3 to 4 months post-TAVI), along with dietary questionnaires to account for potential confounding factors. This observational study aims to highlight the potential relationship between cardiac function and the gut microbiome, offering new perspectives for targeted therapeutic strategies in cardiovascular disease.
详细描述
Hypothesis The interaction between transcatheter aortic valve implantation (TAVI) and the gut microbiota represents an emerging field of investigation with potential clinical implications. Beyond restoring haemodynamic function, TAVI may influence the composition and function of the gut microbiome through several mechanisms. Improved cardiac output following TAVI enhances splanchnic perfusion, potentially reducing mucosal oedema and congestion, which may restore intestinal permeability and lead to favourable changes in microbiome composition.
Study Objective To evaluate changes in the gut microbiota following TAVI in patients with severe aortic valve stenosis.
Study Timeline and Data Collection Phase 1: Screening and Baseline Data Collection (1 month to 24 hours before TAVI, T1) Participants will be assessed for eligibility based on inclusion/exclusion criteria. Informed consent will be obtained, and participants will agree to telephone follow-up.
Collected data will include:
- Demographics and anthropometrics: sex, age, weight, height, BMI
- Social history: smoking, alcohol, substance use
- Medical history: comorbidities including hypertension, diabetes, dyslipidaemia, vascular disease, heart failure, stroke, TIA, embolism, PE
- Echocardiography parameters
- Venous Blood Sample (T1):
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
- •Aortic stenosis suitable for TAVI
排除标准
- •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.
结局指标
主要结局
Change in gut microbiota composition (via 16S rRNA sequencing)
时间窗: 3 months post TAVI
次要结局
- Correlation of microbiota changes with severity of aortic stenosis at baseline(3 months post TAVI)
- Change in serum trimethylamine N-oxide (TMAO) levels(3 months post TAVI)
- Correlation of microbiota changes with haemodynamic parameters(3 months post TAVI)
研究者
Konstantinos Tsioufis
Professor of Cardiology
Hippocration General Hospital