Does Type II Diabetes Influence Prognosis and Left Ventricular Remodeling in Patients With Aortic Valve Stenosis Referred for Aortic Valve Replacement ?
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Left Ventricular Mass measured by echocardiography
研究概览
简要总结
This project focuses on the physiopathology of left ventricular remodeling associated with type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve replacement.
The main objective is to compare the reverse left ventricular remodeling between patients with type II diabetes and case-control patients without diabetes at one(1) year after surgical aortic valve replacement.
The secondary objectives are :
- assess the influence of type II diabetes on left ventricular remodeling in patients presenting with aortic valve stenosis,
- assess the predictive value of myocardial fibrosis and other LV characteristics present prior to aortic valve surgery on the LV reverse remodeling and their influence on cardiovascular events at one (1) year after surgery,
- assess the influence of type II diabetes on cardiovascular morbidity and mortality post aortic valve surgery.
The investigators main hypothesis is that patients with type II diabetes and aortic valve stenosis requiring aortic valve replacement have poorer LV function and less favorable post surgery clinical outcomes than patients without type II diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age > 18 years
- •Arm 1: Treated Type II diabetes, Arm 2: absence of type II diabetes
- •Aortic valve stenosis
- •LVEF > 50% with no kinetic abnormalities
- •Non significant obstructive coronary artery disease
- •Absence of gadolinium enhanced MRI contraindications
- •Informed consent signed
- •Patient affiliated to the French Social Security.
排除标准
- •Chronic arrhythmia or absence of sinus rhythm
- •Past history of cardiomyopathy or coronary insufficiency
- •Significant coronaropathy seen during the coronary angiography with >50% degree stenosis prior to aortic valve replacement
- •Hemodynamically significant valvular dysfunction other than aortic stenosis (grade 2 mitral or aortic insufficiency, mitral valve stenosis < 1.5 cm2)
- •Systemic chronic inflammatory disease leading to cardiac injury (scleroderma)
- •Renal insufficiency (clearance < 30 ml/min)
- •Insufficient transthoracic echocardiography echogenicity
- •Type I diabetes mellitus
- •Uncontrolled hypertension (> 180/100 mm Hg)
结局指标
主要结局
Left Ventricular Mass measured by echocardiography
时间窗: Primary outcome is assessed at one year 1 year after aortic valve replacement.
次要结局
- Magnetic Resonance Imaging (MRI) parameters.(1 year after aortic valve replacement.)
- Measurement of BNP (Brain Natriuretic Peptide).(1 year after aortic valve replacement.)
- Echocardiographic parameters.(1 year after aortic valve replacement.)
- cardiovascular events (cardiac mortality, heart failure, atrial or ventricular rhythm abnormalities) and clinical improvement (NYHA class, 6-minute walk test).(1 year after aortic valve replacement.)