Mitral Valve in Hypertrophic Cardiomyopathy

Not Applicable

Completed

• Conditions: Hypertrophic Obstructive Cardiomyopathy
• Interventions: Procedure: septal myectomy + secondary chordae transection; Procedure: isolated septal myectomy; Procedure: septal myectomy + edge-to-edge mitral valve repair; Procedure: septal myectomy + posterior leaflet sliding plasty

• Registration Number: NCT03877731
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

Brief Summary

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

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 Timeline

• Study Start: 2006-12-01
• Status Verified: 2019-03
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-18
• Primary Completion: 2019-05-30
• Study Completion: 2019-09-01
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hypertrophic cariomyopathy, septal myectomy + chordae	septal myectomy + secondary chordae transection	Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and secondary chordae transection
hypertrophic cariomyopathy, isolated septal myectomy	isolated septal myectomy	Patients with hypertrophic obstructive cardiomyopathy who will undergo isolated septal myectomy
hypertrophic cariomyopathy, septal myectomy + edge-to-edge	septal myectomy + edge-to-edge mitral valve repair	Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and edge-to-edge mitral valve repair (O. Alfieri technique)
hypertrophic cariomyopathy, septal myectomy + sliding plasty	septal myectomy + posterior leaflet sliding plasty	Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and posterior leaflet sliding plasty ( A. Carpentier technique)

Primary Outcome Measures

Name	Time	Method
Event-free survival	5 years	patients' survival without hospital admissions due to the recurring sympthoms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cardiology research institute, National Research Medical Center of the Russian Academy of Sciences; 🇷🇺 Tomsk, Russian Federation