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Mitral Valve in Hypertrophic Cardiomyopathy

Primary Purpose

Hypertrophic Obstructive Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
isolated septal myectomy
septal myectomy + edge-to-edge mitral valve repair
septal myectomy + posterior leaflet sliding plasty
septal myectomy + secondary chordae transection
Sponsored by
Tomsk National Research Medical Center of the Russian Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Obstructive Cardiomyopathy focused on measuring hypertrophic cardiomyopathy, mitral valve, echocardiography

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Experimental

Experimental

No Intervention

No Intervention

Arm Label

hypertrophic cariomyopathy, isolated septal myectomy

hypertrophic cariomyopathy, septal myectomy + edge-to-edge

hypertrophic cariomyopathy, septal myectomy + sliding plasty

hypertrophic cariomyopathy, septal myectomy + chordae

Arterial hypertension + left ventricular hypertrophy

Control

Arm Description

Patients with hypertrophic obstructive cardiomyopathy who will undergo isolated septal myectomy

Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and edge-to-edge mitral valve repair (O. Alfieri technique)

Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and posterior leaflet sliding plasty ( A. Carpentier technique)

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

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

Patients without structural heart disease whose mitral valve geometry and papillary muscles' function will be compared to those of the patients with hypertrophic cardiomyopathy

Outcomes

Primary Outcome Measures

Event-free survival
patients' survival without hospital admissions due to the recurring sympthoms

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2019
Last Updated
January 10, 2020
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03877731
Brief Title
Mitral Valve in Hypertrophic Cardiomyopathy
Official Title
Role of Mitral Valve in the Obstruction of Left Ventricular Outflow Tract in Patients With Hypertrophic Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2006 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Obstructive Cardiomyopathy
Keywords
hypertrophic cardiomyopathy, mitral valve, echocardiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hypertrophic cariomyopathy, isolated septal myectomy
Arm Type
Active Comparator
Arm Description
Patients with hypertrophic obstructive cardiomyopathy who will undergo isolated septal myectomy
Arm Title
hypertrophic cariomyopathy, septal myectomy + edge-to-edge
Arm Type
Experimental
Arm Description
Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and edge-to-edge mitral valve repair (O. Alfieri technique)
Arm Title
hypertrophic cariomyopathy, septal myectomy + sliding plasty
Arm Type
Experimental
Arm Description
Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and posterior leaflet sliding plasty ( A. Carpentier technique)
Arm Title
hypertrophic cariomyopathy, septal myectomy + chordae
Arm Type
Experimental
Arm Description
Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and secondary chordae transection
Arm Title
Arterial hypertension + left ventricular hypertrophy
Arm Type
No Intervention
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients without structural heart disease whose mitral valve geometry and papillary muscles' function will be compared to those of the patients with hypertrophic cardiomyopathy
Intervention Type
Procedure
Intervention Name(s)
isolated septal myectomy
Intervention Type
Procedure
Intervention Name(s)
septal myectomy + edge-to-edge mitral valve repair
Intervention Type
Procedure
Intervention Name(s)
septal myectomy + posterior leaflet sliding plasty
Intervention Type
Procedure
Intervention Name(s)
septal myectomy + secondary chordae transection
Primary Outcome Measure Information:
Title
Event-free survival
Description
patients' survival without hospital admissions due to the recurring sympthoms
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Residual left vetricular outflow tract gradient
Description
left ventricular outflow tract gradient measured by continuous doppler from 5-chamber apical view
Time Frame
5 years
Title
Mitral regurgitation
Description
degree of mitral regurgitation assessed by color doppler, regurgitant volume measured using PISA method
Time Frame
5 years
Title
Papillary muscles' funcion
Description
papillary muscles' strain and strain rate assessed by 2D speckle tracking imaging
Time Frame
5 years
Title
Mitral valve geometry
Description
indices of mitral valve geometry assessed by 2D transthoracic and transesophageal echocardiography and mitral valve quantification analysis
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Pavlyukova, MD, PhD
Organizational Affiliation
Cardiology Research Institute, Tomsk NRMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology research institute, National Research Medical Center of the Russian Academy of Sciences
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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Mitral Valve in Hypertrophic Cardiomyopathy

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