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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02492399
• Other study ID #: 12-435
• Status: Recruiting
• Phase: N/A
• First received: July 1, 2015
• Last updated: July 7, 2015
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Intervention

Procedure:
• extended myectomy
The scheme of extended septal myectomy: Two parallel incisions were made into the septal bulge and connected to remove the muscle mass. Myectomy was extended to the base of the papillary muscles, when midseptal thickening was present. The papillary muscles were grasped and pushed medially to visualize the abnormal connections between the papillary muscles and the anterior wall of the ventricle. A blade was used to divide the thickened abnormal attachments. A pituitary rongeur may be used to resect a portion of the junction of the papillary and lateral wall. This reduces the diameter of the papillary muscle and allows for posterior displacement of the anterior mitral leaflet. Division of abnormal attachments and thinning of the papillary muscles is critical for the treatment of SAM.
• myectomy by Morrow
A first myotomy is made into the septum just below the base of the right coronary leaflet at a point 2-3 mm to the right of the commissure between the left and right coronary leaflets. A second myotomy is made in the same manner, parallel to the first one and about 1 cm to the right of it. The two vertical myotomies are made and cornnected transversely in the interventricular septum. The muscle bar is then grasped with the angled rongeur and the instrument is pushed firmly toward the apex, peeling the mtusele from its anterior septal attachments. After completion of the resectioni, a rectangular channel about 1 X 1.5 cm is palpable from the valve ring toward the apex for a dis- tance of about 4 cm.

Locations

Country	Name	City	State
Russian Federation	Novosibirsk State Research Institute of Circulation Pathology	Novosibirsk	Novosibirsk territory

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pressure gradient in the output section of the left ventricle		one year	No
Secondary	The function of the mitral valve	(Residual mitral regurgitation, SAM syndrome)	one year	No