Mitral Valve in Hypertrophic Cardiomyopathy

NCT ID: NCT03877731

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-01
• Study Completion Date: 2019-09-01

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.

Conditions

Hypertrophic Obstructive Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hypertrophic cariomyopathy, isolated septal myectomy

Patients with hypertrophic obstructive cardiomyopathy who will undergo isolated septal myectomy

Group Type: ACTIVE_COMPARATOR

isolated septal myectomy

Intervention Type: 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)

Group Type: EXPERIMENTAL

septal myectomy + edge-to-edge mitral valve repair

Intervention Type: 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)

Group Type: EXPERIMENTAL

septal myectomy + posterior leaflet sliding plasty

Intervention Type: PROCEDURE

hypertrophic cariomyopathy, septal myectomy + chordae

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

Group Type: EXPERIMENTAL

septal myectomy + secondary chordae transection

Intervention Type: 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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

isolated septal myectomy

Intervention Type: PROCEDURE

septal myectomy + edge-to-edge mitral valve repair

Intervention Type: PROCEDURE

septal myectomy + posterior leaflet sliding plasty

Intervention Type: PROCEDURE

septal myectomy + secondary chordae transection

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena Pavlyukova, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Research Institute, Tomsk NRMC

Locations

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

Tomsk, , Russia

Countries

Russia

Other Identifiers

HCMP-MV151

Identifier Type: -

Identifier Source: org_study_id