跳至主要内容
临床试验/NCT04329689
NCT04329689Unknown不适用

Hypertrophic ObsructiveCardiomyopathy:Should the Mitral Valve be Addressed During Septal Myectomy?

Assiut University0 个研究点目标入组 98 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
98
主要终点
LVOT obstruction degree in cm by Echocardiography

研究概览

简要总结

Hypertrophic Obstructive cardiomyopathy (HOCM) is the most common genetic cardiomyopathy, heterogeneous in phenotype and clinical course. The genotype-phenotype relationship and associated molecular mechanisms are still incompletely understood. In the HOCM milieu, increased energy cost of force production, impairing performance and mitochondrial function, may be associated to patients' genotype and/or phenotype

详细描述

Hypertrophic Obstructive cardiomyopathy (HOCM) is the most common genetic cardiomyopathy, heterogeneous in phenotype and clinical course. The genotype-phenotype relationship and associated molecular mechanisms are still incompletely understood. In the HOCM milieu, increased energy cost of force production, impairing performance and mitochondrial function, may be associated to patients' genotype and/or phenotype (1).

Hypertrophic cardiomyopathy as a clinical entity was first described by Brock in 1957 (2). Hypertrophic cardiomyopathy is the most common cause of sudden cardiac death in young people, including competitive athletes (3).

The characteristic pathologic features of hypertrophic cardiomyopathy are asymmetric hypertrophy, especially of the interventricular septum myocardial fiber hypertrophy and disorganisation of myocardial cells, abnormal thickened intramyocardial coronary vessels ("small vessel disease") and interstitial fibrosis (4). In the majority of patients (approximately 90%), hypertrophy mainly involves the interventricular septum and anterolateral wall. In a minority of patients myocardial hypertrophy is confined to the apical part of the left ventricle (4).

Myocardial hypertrophy is not the only hallmark of hypertrophic Obsructive cardiomyopathy. Klues et al. have described anatomic alterations in the mitral apparatus which may be present in this disorder: an increase of the mitral valve area, increase in length of the anterior leaflet, abnormal laxity and anterior displacement of the valve (5). Mitral valve (MV) leaflets have an important role in the pathophysiological process of left ventricular (LV) outflow tract obstruction in patients with hypertrophic obstructive cardiomyopathy (HOCM). Systolic anterior motion (SAM) of the mitral apparatus and contact of the leaflets with the hypertrophied septum narrow the LV outflow, leading to dynamic pressure gradients and in many patients, mitral regurgitation (MR) (6).

Currently, surgery is the gold standard treatment for most drug refractory and severely symptomatic patients [New York Heart Association (NYHA) class III or IV] with obstructive HOCM [7].

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All patients that present with hypertrophic obstructive cardiomyopathy (HOCM) with mean pressure gradient>50 mm Hg at rest or on provocation
  • HOCM patients with severe mitral regurgitation.
  • HOCM patients with New York Heart Association (NYHA) functional class II to IV despite optimal medical treatment consisting of -blocking agents, calcium channel blockers, or both.

排除标准

  • b. Exclusion criteria:
  • Non-obstructive physiological characteristics.
  • Previous MV surgery.
  • Patient with intrinsic pathology of the mitral valve.
  • Patients <18 years.

结局指标

主要结局

LVOT obstruction degree in cm by Echocardiography

时间窗: 3 months

The degree of the LVOT obstruction as measured in cm by echocardiography .

Systolic anterior motion of mitral valve

时间窗: 3 months

The presence of systolic anterior motion of mitral valve as assessed by post-operative echocardiography.

次要结局

  • Post-Operative complictions(3 months)
  • Post-operative mortality(3 months)
  • post-operative general condition(3 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heba Abdelkareem Hussein

Doctor

Assiut University

相似试验

Hyp Obst Cardiomyopathy | 临床试验