Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mitral Valve in Hypertrophic Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03877731
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Hypertrophic Obstructive Cardiomyopathy Procedure: 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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Mitral Valve in the Obstruction of Left Ventricular Outflow Tract in Patients With Hypertrophic Cardiomyopathy
Actual Study Start Date : December 1, 2006
Actual Primary Completion Date : May 30, 2019
Estimated Study Completion Date : September 1, 2019


Arm Intervention/treatment
Active Comparator: hypertrophic cariomyopathy, isolated septal myectomy
Patients with hypertrophic obstructive cardiomyopathy who will undergo isolated septal myectomy
Procedure: isolated septal myectomy
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)
Procedure: septal myectomy + edge-to-edge mitral valve repair
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)
Procedure: septal myectomy + posterior leaflet sliding plasty
Experimental: hypertrophic cariomyopathy, septal myectomy + chordae
Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and secondary chordae transection
Procedure: septal myectomy + 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
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



Primary Outcome Measures :
  1. Event-free survival [ Time Frame: 5 years ]
    patients' survival without hospital admissions due to the recurring sympthoms


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877731


Contacts
Layout table for location contacts
Contact: Alexander Kanev, MD +7 952 880 0082 alexkanev92@gmail.com
Contact: Elena Pavlyukova, MD, PhD +7 960 977 8698 pavlyukovaelena@yandex.ru

Locations
Layout table for location information
Russian Federation
Cardiology research institute, National Research Medical Center of the Russian Academy of Sciences Recruiting
Tomsk, Russian Federation, 634012
Contact: Alexander Kanev, MD    +7 952 880 0082    alexkanev92@gmail.com   
Principal Investigator: Elena Pavlukova, MD         
Principal Investigator: Alexei Evtushenko, MD         
Principal Investigator: Alexander Kanev, MD         
Sub-Investigator: Konstantin Smishlyaev, MD         
Sponsors and Collaborators
Tomsk National Research Medical Center of the Russian Academy of Sciences
Investigators
Layout table for investigator information
Principal Investigator: Elena Pavlyukova, MD, PhD Cardiology Research Institute, Tomsk NRMC

Layout table for additonal information
Responsible Party: Tomsk National Research Medical Center of the Russian Academy of Sciences
ClinicalTrials.gov Identifier: NCT03877731     History of Changes
Other Study ID Numbers: HCMP-MV151
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tomsk National Research Medical Center of the Russian Academy of Sciences:
hypertrophic cardiomyopathy, mitral valve, echocardiography
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases