Clinical trial NCT02492399: Comparisonof Extended Myoectomy and Myoectomy by Morrow in Patients With Hypertrophic Obstructive Cardiomyopathy (HOCM)
Official title: Compare the Results for the Extended Myoectomy and Standard Morrow's Myoectomy in Patients With Ventricular Obstruction of the Left Ventricular Output
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertrophic Obstructive Cardiomyopathy
Keywords: hypertrophic cardiomyopathy
mitral valve
SAM syndrome
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2015-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the application of the extended myoectomy in patients with obstruction of the left ventricular output more efficient than standard myoectomy by Morrow.

Detailed description: Many years myoectomy for Morrow was the gold standard in the treatment of obstructive hypertrophic cardiomyopathy. Currently more retrospective data in the literature about the good results the extended septal myectomy. Use of extended myomectomy eliminates mitral insufficiency due to SAM syndrome. The question remains whether it is possible at hypertrophic cardiomyopathy basal part and mediated mitral insufficiency use only myoectomy by Morrow is achieved regression SAM syndrome and release output of the left ventricle. Planned to create two equal groups of 30 people that will use two methods of surgical treatment of obstructive hypertrophic cardiomyopathy. The study will be terminated in the event of complete AV block more than 2% and unsatisfactory results of a myoectomy requiring perform mitral valve replacement in more than 15% of the patients studied. The study assumed crossover: in case of failure elimination SAM syndrome and mediated mitral insufficiency myoectomy by Morrow for patients will perform extended myoectomy in the case of a good result in patients are moved to the second group.

Planned studies the long-term and immediate results of operations:

* Quantitative determination of enzymes of myocardial injury: creatine phosphokinase MB and troponin I.
* Determination of atrial natriuretic peptide (ANP) and brain natriuretic peptide (VNP).
* MRI with contrast heart to assess remodeling of the heart chambers and heart weight measurements.
* TEE evaluation function and mitral valve gradient at the output of the left ventricle.

Eligibility criteria: Inclusion Criteria:

* Able to sign Informed Consent and Release of Medical Information forms
* Age ≥ 18 years
* obstructive hypertrophic cardiomyopathy
* mediated mitral insufficiency by SAM syndrome
* II-IV (NYHA),
* average systolic pressure gradient greater than 50 mm Hg. Art. at rest;
* basal or medium ventricular obstruction

Exclusion Criteria:

* Related defect of the aortic valve;
* Organic mitral valve disease (dysplasia, rheumatic fever, infective endocarditis);
* Surgically significant coronary artery lesions;
* Patients requiring implantation of a cardioverter-defibrillator

Primary outcomes:
measure: The pressure gradient in the output section of the left ventricle
timeFrame: one year
Secondary outcomes:
measure: The function of the mitral valve
timeFrame: one year
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Research Institute of Circulation Pathology
state: Novosibirsk territory
Study officials:
affiliation: Meshalkin Research Institute of Pathology of Circulation
name: Aleksandr V Bogachev-Prokophiev, PhD
role: PRINCIPAL_INVESTIGATOR
References: