Expression of Sodium Glucose Co-transporter2 in Myocardium From Patients With Aortic Valve Stenosis and With/Without Diastolic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To study the expression levels of SGLT2 in the myocardium of patients with surgical aortic stenosis
研究概览
简要总结
The aim of the study is to evaluate the expression of Sodium Glucose Co-transporter 2 (SGLT2) in myocardium from patients with aortic stenosis. 2 groups of patients will be defined: Group A with diastolic heart failure and Group B without heart failure. The expression of SGLT2 will be measured on small myocardium specimens harvested during aortic valve replacement operation. This study should allow us to better understand the effect of glifozines in human heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults over 18 years-old
- •Patient with surgical aortic valve stenosis, with or without heart failure, in two equal-sized groups (40 subjects in each group)
- •Subjects affiliated with a social security health insurance plan
- •Subject able to understand the objectives and risks of the research and to give dated and signed informed consent
排除标准
- •Infective endocarditis in aortic stenosis
- •Severe coronary pathology associated with aortic stenosis
- •Impossible to give the subject informed information (subject in emergency situation, difficulties in understanding the subject, ...)
- •Subject under legal protection
- •Subject under guardianship or curatorship
- •Pregnancy and/or breastfeeding
研究组 & 干预措施
patients with aortic valve stenosis with heart failure
干预措施: Myocardium biopsy (Biological)
patients with aortic valve stenosis without heart failure
干预措施: Myocardium biopsy (Biological)
结局指标
主要结局
To study the expression levels of SGLT2 in the myocardium of patients with surgical aortic stenosis
时间窗: Day 0
Measure of SGLT2 expression level by RT-PCR and
To study the SGLT2 tissue localization in the myocardium of patients with surgical aortic stenosis
时间窗: Day 0
SGLT2 expression level by immunofluorescence labeling
次要结局
- Evaluate the pro-thrombotic response(Day 0)
- Evaluate the pro-inflammatory response by analysing the expression level of tissue activation molecules VCAM-1, ICAM-1, MCP-1(Day 0)
- Evaluate the pro-senescent response(Day 0)
- Evaluate endothelial dysfunction(Day 0)
- Comparison of SGLT2 expression levels between heart failure and non-heart failure patients.(Day 0)
- Assess oxidative stress(Day 0)
- Evaluate the pro-fibrotic response(Day 0)