Concentration of Trimethylamine-N-oxide Versus Echocardiographic, Biochemical and Histopathological Parameters of Heart Failure in Patients With Severe Aortic Stenosis: a Prospective, Observatory Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Correlation between the serum and urine trimethylamine N-oxide concentration and aortic valve area index
研究概览
简要总结
Trimethylamine N-oxide (TMAO) has recently gained increasing scientific interest in the field of cardiovascular disease, including its role in cell protection against osmotic and hydrostatic stress. Aortic stenosis (AS) is the most common valvular heart disease, affecting about 7.6 million people over 75 years of age in North America and Europe alone. We hypothesized that TMAO plays a role in protection of the cardiomyocytes against pressure overload in patients with AS. The primary aim of this study is to assess the correlation between the serum and urine TMAO concentration, and (i) echocardiographic, (ii) biochemical and (iii) histopathological parameters of heart failure in patients with severe AS. The secondary aim of this study is to evaluate a correlation between the baseline TMAO concentrations and the post-treatment clinical status, as well as the post-treatment echocardiographic and biochemical parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent to participate in the study
- •Severe aortic stenosis, defined as aortic valve area <1.0 cm2 or aortic valve area index <0.6 cm2/m2 as calculated by the continuity equation on transthoracic echocardiography, regardless of the transvalvular gradient, with or without coexisting symptoms of heart failure
- •Qualification for surgical aortic valve replacement or transcatheter aortic valve implantation by the Heart Team in accordance with European Society of Cardiology guidelines
排除标准
- •Heart failure of etiology other than aortic stenosis
- •Coexisting, haemodynamically significant aortic regurgitation
- •Myocardial infarction within the last 3 months
- •Coronary revascularization within the last month or planned during transcatheter aortic valve implantation or surgical aortic valve replacement
- •Chronic kidney disease with estimated glomerular filtration rate <45 ml/min/1.73 m2
- •Acute gastrointestinal disease within the last month
- •Active neoplastic disease
- •Chronic inflammatory disease
- •Autoimmune disease
- •Chronic intestinal disease
- •Antibiotic therapy within the last 2 months
- •Dietary supplements within the last 7 days
结局指标
主要结局
Correlation between the serum and urine trimethylamine N-oxide concentration and aortic valve area index
时间窗: January 15, 2019 - February 15, 2023
次要结局
- Correlation between the serum and urine trimethylamine N-oxide concentration and (i) other echocardiographic, (ii) biochemical and (iii) histopathological parameters of heart failure.(January 15, 2019 - February 15, 2023)
- Correlation between the baseline trimethylamine N-oxide concentrations and the post-treatment clinical status, as well as the post-treatment echocardiographic and biochemical parameters.(January 15, 2019 - February 15, 2023)