Mitral Valve in Hypertrophic Cardiomyopathy
June 23, 2026 updated by: Tomsk National Research Medical Center of the Russian Academy of Sciences
Role of Mitral Valve in the Obstruction of Left Ventricular Outflow Tract in Patients With 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
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Tomsk, Russia, 634012
- Cardiology research institute, National Research Medical Center of the Russian Academy of Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: hypertrophic cariomyopathy, isolated septal myectomy
Patients with hypertrophic obstructive cardiomyopathy who will undergo isolated septal myectomy
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|
|
Experimental: 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)
|
|
|
Experimental: hypertrophic cariomyopathy, septal myectomy + sliding plasty
Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and posterior leaflet sliding plasty ( A. Carpentier technique)
|
|
|
Experimental: hypertrophic cariomyopathy, septal myectomy + chordae
Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and secondary chordae transection
|
|
|
No Intervention: 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
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|
|
No Intervention: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Event-free survival
Time Frame: 5 years
|
patients' survival without hospital admissions due to the recurring sympthoms
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Residual left vetricular outflow tract gradient
Time Frame: 5 years
|
left ventricular outflow tract gradient measured by continuous doppler from 5-chamber apical view
|
5 years
|
|
Mitral regurgitation
Time Frame: 5 years
|
degree of mitral regurgitation assessed by color doppler, regurgitant volume measured using PISA method
|
5 years
|
|
Papillary muscles' funcion
Time Frame: 5 years
|
papillary muscles' strain and strain rate assessed by 2D speckle tracking imaging
|
5 years
|
|
Mitral valve geometry
Time Frame: 10 days
|
indices of mitral valve geometry assessed by 2D transthoracic and transesophageal echocardiography and mitral valve quantification analysis
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Elena Pavlyukova, MD, PhD, Cardiology Research Institute, Tomsk NRMC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2006
Primary Completion (Actual)
May 30, 2019
Study Completion (Actual)
September 1, 2019
Study Registration Dates
First Submitted
March 11, 2019
First Submitted That Met QC Criteria
March 14, 2019
First Posted (Actual)
March 18, 2019
Study Record Updates
Last Update Posted (Actual)
June 26, 2026
Last Update Submitted That Met QC Criteria
June 23, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRI-151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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