Role of Mitral Valve in the Obstruction of Left Ventricular Outflow Tract in Patients With Hypertrophic Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Event-free survival
研究概览
简要总结
The purpose of the study is to assess the role of mitral valve apparatus in the development of outflow tract obstruction in patients with hypertrophic cardiomyopathy and to identify the best surgical treatment modality to relieve outflow tract obstruction in such patients
详细描述
It is well-known that mitral valve plays an important role in the development of left ventricular outflow tract obstruction in patients with hypertrophic cardiomyopathy. In order to further investigate this phenomenon, the following study aims to compare mitral valve geometry indices, as assessed by transthoracic echocardiography, two- and three-dimentional transesophageal echocardiography and mitral valve quantification analysis, and papillary musles' function, as assessed by 2D speckle tracking imaging, in patients with hypertrophic obstructive cardiomyopathy, patients with arterial hypertension and left ventricular hypertrophy and people without structural heart disease. This will provide information on the geometric characteristics of mitral valve that predispose to the development of obstruction. Futhermore, patients with hypertrophic obstructive cardiomyopathy that are eligible for the surgical relief of obstruction will be randomised into four groups according to the modality of intervention. These groups are as follows: 1) isolated extended septal myectomy; 2) extended septal myectomy + edge to edge mitral valve repair; 3) extended septal myectomy + posterior lealfet sliding plasty; 4) extended septal myectomy + secondary chordae transection. After surgery, said indices will be reassessed and the degree of outflow tract obstruction relief noted, in order to elicit which geometrical changes are produced by each type of intervention. Patients will be followed long-term, up to 5 years, in order to define whether the addition of the intervention on mitral valve helps abolish the residual gradient more effectively, and whether it translates into any survival benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18 years
- •Signed informed consent to participate in the study
- •For patients with hypertrophic cardiomyopathy only: resting or latent peak left ventricular outflow tract gradient >50 mmHg, NYHA class III-IV
- •For patients with arterial hypertension only: hystory of arterial pressure increase >140/90 mmHg, increased left vantricular wall thickness (>10 mm) and myocardial mass indexed to BSA (>95 g/m2 for women and >115 g/m2 for men), as assessed by 2D transthoracic echocardiography
排除标准
- •Age < 18 years
- •Persistent form of atrial fibrillation
- •Intrinsic mitral or aortic valve disease
- •Coronary artery disease
- •Reduced left ventricular ejection fraction
- •For control group only: presence of any structural heart disease
研究组 & 干预措施
hypertrophic cariomyopathy, isolated septal myectomy
Patients with hypertrophic obstructive cardiomyopathy who will undergo isolated septal myectomy
干预措施: isolated septal myectomy (Procedure)
hypertrophic cariomyopathy, septal myectomy + edge-to-edge
Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and edge-to-edge mitral valve repair (O. Alfieri technique)
干预措施: septal myectomy + edge-to-edge mitral valve repair (Procedure)
hypertrophic cariomyopathy, septal myectomy + sliding plasty
Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and posterior leaflet sliding plasty ( A. Carpentier technique)
干预措施: septal myectomy + posterior leaflet sliding plasty (Procedure)
hypertrophic cariomyopathy, septal myectomy + chordae
Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and secondary chordae transection
干预措施: septal myectomy + secondary chordae transection (Procedure)
Arterial hypertension + left ventricular hypertrophy
Patients with arterial hypertension with left ventricular hypertrophy whose mitral valve geometry and papillary muscles' function will be compared to those of the patients with hypertrophic cardiomyopathy
Control
Patients without structural heart disease whose mitral valve geometry and papillary muscles' function will be compared to those of the patients with hypertrophic cardiomyopathy
结局指标
主要结局
Event-free survival
时间窗: 5 years
patients' survival without hospital admissions due to the recurring sympthoms
次要结局
- Papillary muscles' funcion(5 years)
- Mitral valve geometry(10 days)
- Residual left vetricular outflow tract gradient(5 years)
- Mitral regurgitation(5 years)
