Clinical trial NCT03877731: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic Obstructive Cardiomyopathy
Keywords: hypertrophic cardiomyopathy, mitral valve, echocardiography
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Event-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Residual left vetricular outflow tract gradient
timeFrame: 5 years
measure: Mitral regurgitation
timeFrame: 5 years
measure: Papillary muscles' funcion
timeFrame: 5 years
measure: Mitral valve geometry
timeFrame: 10 days
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Cardiology research institute, National Research Medical Center of the Russian Academy of Sciences
Study officials:
affiliation: Cardiology Research Institute, Tomsk NRMC
name: Elena Pavlyukova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: