Mitral Valve in Hypertrophic Cardiomyopathy

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status: Completed

Conditions: Hypertrophic Obstructive Cardiomyopathy

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT03877731

HCMP-MV151

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 6 patient groups

hypertrophic cariomyopathy, isolated septal myectomy

Active Comparator group

Description:

Patients with hypertrophic obstructive cardiomyopathy who will undergo isolated septal myectomy

Treatment:

Procedure: isolated septal myectomy

hypertrophic cariomyopathy, septal myectomy + edge-to-edge

Experimental group

Description:

Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and edge-to-edge mitral valve repair (O. Alfieri technique)

Treatment:

Procedure: septal myectomy + edge-to-edge mitral valve repair

hypertrophic cariomyopathy, septal myectomy + sliding plasty

Experimental group

Description:

Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and posterior leaflet sliding plasty ( A. Carpentier technique)

Treatment:

Procedure: septal myectomy + posterior leaflet sliding plasty

hypertrophic cariomyopathy, septal myectomy + chordae

Experimental group

Description:

Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and secondary chordae transection

Treatment:

Procedure: septal myectomy + secondary chordae transection

Arterial hypertension + left ventricular hypertrophy

No Intervention group

Description:

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

No Intervention group

Description:

Patients without structural heart disease whose mitral valve geometry and papillary muscles' function will be compared to those of the patients with hypertrophic cardiomyopathy