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

Not Applicable

• Conditions: Hypertrophic Obstructive Cardiomyopathy
• Interventions: Procedure: myectomy by Morrow; Procedure: extended myectomy

• Registration Number: NCT02492399
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-19
• Last Update Posted: 2016-03-22
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
myectomy by Morrow	myectomy by Morrow	Procedure: myectomy by Morrow. Will be included in a group of 30 patients with obstructive hypertrophic cardiomyopathy and mitral insufficiency. In the case of conservation SAM syndrome and mediated mitral insufficiency, the result will be read as unsatisfactory. Patients will perform advanced myoectomy. All patients who need to be supplemented by the operation extension myoectomy subsequently run out in the second group. When it is impossible to eliminate mediated mitral regurgitation without mitral valve replacement, patients performed myoectomy and mitral valve replacement. The result in this case is read as completely unsatisfactory. Upon reaching 15% replacement mitral valve study terminated. Evaluation results will be made myoectomy as TEE and direct tensiometer.
extended myectomy	extended myectomy	Procedure: extended myectomy. Will be included in a group of 30 patients with obstructive hypertrophic cardiomyopathy and mitral insufficiency. Intraoperatively for all patients will be executed TEE to calculate the volume of excision. All patients will be performed extended myoectomy which supplemented resection and release of the papillary muscles. In case of unsatisfactory MV repair will reconnect the device artificial circulation and mitral valve replacement. The result in this case will become engrossed in reading as completely unsatisfactory. At achievement of 15% prosthetics of the mitralny valve research stops. Evaluation results will be made myoectomy as TEE and direct tensiometer .

Primary Outcome Measures

Name	Time	Method
The pressure gradient in the output section of the left ventricle	one year

Secondary Outcome Measures

Name	Time	Method
The function of the mitral valve	one year	(Residual mitral regurgitation, SAM syndrome)

Trial Locations

Locations (1)

Novosibirsk State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Novosibirsk territory, Russian Federation