Mitral Valve in Hypertrophic Cardiomyopathy

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Role of Mitral Valve in the Obstruction of Left Ventricular Outflow Tract in Patients With Hypertrophic Cardiomyopathy

Conditions
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Hypertrophic Obstructive Cardiomyopathy

Intervention / Treatment
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* Procedure: isolated septal myectomy
* Procedure: septal myectomy + edge-to-edge mitral valve repair
* Procedure: septal myectomy + posterior leaflet sliding plasty
* Procedure: septal myectomy + secondary chordae transection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hypertrophic cariomyopathy, isolated septal myectomy<br>Patients with hypertrophic obstructive cardiomyopathy who will undergo isolated septal myectomy | Procedure: isolated septal myectomy<br> <br> |
| Experimental: hypertrophic cariomyopathy, septal myectomy + edge-to-edge<br>Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and edge-to-edge mitral valve repair (O. Alfieri technique) | Procedure: septal myectomy + edge-to-edge mitral valve repair<br> <br> |
| Experimental: hypertrophic cariomyopathy, septal myectomy + sliding plasty<br>Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and posterior leaflet sliding plasty ( A. Carpentier technique) | Procedure: septal myectomy + posterior leaflet sliding plasty<br> <br> |
| Experimental: hypertrophic cariomyopathy, septal myectomy + chordae<br>Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and secondary chordae transection | Procedure: septal myectomy + secondary chordae transection<br> <br> |
| No Intervention: Arterial hypertension + left ventricular hypertrophy<br>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 | |
| No Intervention: Control<br>Patients without structural heart disease whose mitral valve geometry and papillary muscles' function will be compared to those of the patients with hypertrophic cardiomyopathy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival | patients' survival without hospital admissions due to the recurring sympthoms | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual left vetricular outflow tract gradient | left ventricular outflow tract gradient measured by continuous doppler from 5-chamber apical view | 5 years | 
| Mitral regurgitation | degree of mitral regurgitation assessed by color doppler, regurgitant volume measured using PISA method | 5 years | 
| Papillary muscles' funcion | papillary muscles' strain and strain rate assessed by 2D speckle tracking imaging | 5 years | 
| Mitral valve geometry | indices of mitral valve geometry assessed by 2D transthoracic and transesophageal echocardiography and mitral valve quantification analysis | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertrophic cardiomyopathy, mitral valve, echocardiography