Mitral Valve in Hypertrophic Cardiomyopathy

Tomsk National Research Medical Center of the Russian Academy of Sciences100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Hypertrophic Obstructive Cardiomyopathy

Interventions

isolated septal myectomyPROCEDURE

septal myectomy + edge-to-edge mitral valve repairPROCEDURE

septal myectomy + posterior leaflet sliding plastyPROCEDURE

septal myectomy + secondary chordae transection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cardiology research institute, National Research Medical Center of the Russian Academy of Sciences

Tomsk, Russia

Outcomes

Primary Outcomes

Event-free survival

patients' survival without hospital admissions due to the recurring sympthoms

Time frame: 5 years

Secondary Outcomes

Residual left vetricular outflow tract gradient

left ventricular outflow tract gradient measured by continuous doppler from 5-chamber apical view

Time frame: 5 years

Mitral regurgitation

degree of mitral regurgitation assessed by color doppler, regurgitant volume measured using PISA method

Time frame: 5 years

Papillary muscles' funcion

papillary muscles' strain and strain rate assessed by 2D speckle tracking imaging

Time frame: 5 years

Mitral valve geometry

indices of mitral valve geometry assessed by 2D transthoracic and transesophageal echocardiography and mitral valve quantification analysis

Time frame: 10 days

Data from ClinicalTrials.gov

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