Comparisonof Extended Myoectomy and Myoectomy by Morrow in Patients With Hypertrophic Obstructive Cardiomyopathy (HOCM)

Hypertrophic Obstructive Cardiomyopathy Clinical Trial

Official title: Compare the Results for the Extended Myoectomy and Standard Morrow's Myoectomy in Patients With Ventricular Obstruction of the Left Ventricular Output

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

• NCT number: NCT02492399
• Study type: Interventional
• Source: Meshalkin Research Institute of Pathology of Circulation
• Status: Recruiting
• Phase: N/A
• Start date: January 2014
• Completion date: December 2015