Mitral Valve in Hypertrophic Cardiomyopathy

Hypertrophic Obstructive Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03877731
• Other study ID #: HCMP-MV151
• Status: Completed
• Phase: N/A
• Start date: December 1, 2006
• Est. completion date: September 1, 2019

Study information

• Verified date: March 2019
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 1, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Obstructive Cardiomyopathy
• Hypertrophy

Intervention

Procedure:
• isolated septal myectomy

• septal myectomy + edge-to-edge mitral valve repair

• septal myectomy + posterior leaflet sliding plasty

• septal myectomy + secondary chordae transection

Locations

Country	Name	City	State
Russian Federation	Cardiology research institute, National Research Medical Center of the Russian Academy of Sciences	Tomsk

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival	patients' survival without hospital admissions due to the recurring sympthoms	5 years
Secondary	Residual left vetricular outflow tract gradient	left ventricular outflow tract gradient measured by continuous doppler from 5-chamber apical view	5 years
Secondary	Mitral regurgitation	degree of mitral regurgitation assessed by color doppler, regurgitant volume measured using PISA method	5 years
Secondary	Papillary muscles' funcion	papillary muscles' strain and strain rate assessed by 2D speckle tracking imaging	5 years
Secondary	Mitral valve geometry	indices of mitral valve geometry assessed by 2D transthoracic and transesophageal echocardiography and mitral valve quantification analysis	10 days