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Completed

NCT Number: NCT03877731

Mitral Valve in Hypertrophic Cardiomyopathy

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tomsk, 634012, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Primary outcomes

  1. Event-free survival

    Time frame: 5 years

    patients' survival without hospital admissions due to the recurring sympthoms

Secondary outcomes

  1. Residual left vetricular outflow tract gradient

    Time frame: 5 years

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

  2. Mitral regurgitation

    Time frame: 5 years

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

  3. Papillary muscles' funcion

    Time frame: 5 years

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

  4. Mitral valve geometry

    Time frame: 10 days

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

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2019
Study completion
2019
First posted
Mar 18, 2019
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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