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临床试验/NCT04339582
NCT04339582Unknown不适用

GENETIC BASIS of LEFT VENTRICULAR APICAL HYPOPLASIA

Monaldi Hospital1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年9月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
7
试验地点
1
主要终点
new gene of LVAH

研究概览

简要总结

Brief summary Left ventricular apical hypoplasia (LVAH) is a rare cardiomyopathy characterized by a spherical, truncated LV with some degree of systolic dysfunction, an elongated, normally functioning right ventricle that wraps around the distal left ventricle, deficiency of the myocardium within the LV apex with adipose tissue infiltrating the apex and origin of the papillary muscle in the flattened anterior apex. This condition presents with different clinical presentation, ranging from no symptoms to congestive heart failure or malignant tachycardia. The etiology of this condition is currently unknown. The aim of this study is to evaluate the clinical and genetic characteristics of patients with LVAH.

Background Left ventricular apical hypoplasia (LVAH) is described as congenital heart disease with an unusual type of cardiomyopathy that was first described in 2004 by Fernandez-Valls et al. It is an extremely rare disease; to date, only more than twenty cases were described.

The typical imaging features of this cardiomyopathy include: a spherical, truncated LV with some degree of systolic dysfunction; an elongated, normally functioning right ventricle that wraps around the distal left ventricle; deficiency of the myocardium within the LV apex with adipose tissue infiltrating the apex; origin of the papillary muscle in the flattened anterior apex. A 2D echocardiogram and cardiac MRI can successfully indicate different morphological features This rare phenomenon frequently presents with different clinical manifestations according to the age of the disease, from no symptoms in children to congestive heart failure, pulmonary edema, or even malignant tachycardia in adults. Congenital or genetical etiology was proposed to explain the development of this rare cardiomyopathy.

The aim of this study is to evaluate the clinical and genetic characteristics of patients with LVAH.

Methods Study population

The study population is composed by consecutive patients with diagnosis of LVAH. Diagnosis of LVAH is based on echocardiographic or cardiac magnetic resonance (CMR) evidence of all the following diagnostic criteria:

  • a spherical, truncated LV with some degree of systolic dysfunction;
  • an elongated, normally functioning right ventricle that wraps around the distal left ventricle;
  • deficiency of the myocardium within the LV apex with adipose tissue infiltrating the apex;
  • origin of the papillary muscle in the flattened anterior apex. Patients enrolled followed a common protocol designed by GL (Monaldi Hospital, AORN Colli, University of Campania "Luigi Vanvitelli"). The study protocol was approved, and written informed consent was obtained from each subject, according to the procedure established by the Ethic Committee of our institution.

Study protocol Patients enrolled underwent a comprehensive clinical-genetic evaluation commonly practiced in our cardiology division. In particular, the basal evaluation, consisted family and personal history, physical examination, blood tests, 12-lead electrocardiogram (ECG) at rest, conventional M-mode, two-dimensional and Doppler echocardiography, 24-hour Holter ECG, and cardiac magnetic resonance (CMR), and genetic testing with whole exome sequencing (WES). Moreover, all patients are clinically revaluated every 6-12 months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Male and female patients, 0-90 years old, in any distribution.
  • •Patients who have the diagnostic criteria for LVAH. Diagnosis of LVAH is based on echocardiographic or cardiac magnetic resonance (CMR) evidence of all the following diagnostic criteria:
  • •a spherical, truncated LV with some degree of systolic dysfunction;
  • •an elongated, normally functioning right ventricle that wraps around the distal left ventricle;
  • •deficiency of the myocardium within the LV apex with adipose tissue infiltrating the apex;
  • •origin of the papillary muscle in the flattened anterior apex.

排除标准

  • •Involvement with any other ongoing studies.
  • •Patients who have diagnosis of other Cardiomyopathies

结局指标

主要结局

new gene of LVAH

时间窗: one year later the completation study

the principal aim of the study is to identify the new gene of LVAH and to investigate on genetic background of this clinical condition

次要结局

未报告次要终点

研究者

发起方
Monaldi Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

GIUSEPPE LIMONGELLI

Principal Investigator

Monaldi Hospital

研究点 (1)

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