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临床试验/NCT07567417
NCT07567417尚未招募不适用

Endocrinal Dysfunction Among Children With Dilated Cardiomyopathy at Sohag University Hospital

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1

研究概览

简要总结

All patients in this study will be subjected to the following (as detailed in the attached patient's data sheet).

  1. Clinical History: focusing on:
  • Socio-demographic factors, especially age, gender, family history, and degree of consanguinity.
  • Cardiac symptoms, such as feeding difficulties in the infant, exercise intolerance in older children, fatigue, dyspnea on exertion, heart failure symptoms.
  1. Thorough clinical examination: focusing on:
  • General condition.
  • Anthropometric measures (weight, height, and body mass index).
  • Vital signs (Including HR, BP, SO2, RR, Body temperature).
  • Cardiac examination (including any associated murmur, signs up heart failure).
  1. Severity of heart failure in children with dilated cardiomyopathy For all patients, they were classified according to Children's Ross HF classification.

Children's Ross HF classification is as follows[17]:

Class I: asymptomatic cases.

Class II: mild tachypnea or diaphoresis with feeding in infants, dyspnea on exertion in older children.

Class III: marked tachypnea or diaphoresis with feeding in infants, marked dyspnea on exertion, and prolonged feeding times with growth failure.

Class IV: tachypnea, retractions, grunting, or diaphoresis at rest are examples of symptoms. 4. Data collection: according to attached checklist for every patient involved in the study

详细描述

Dilated cardiomyopathy is defined as "dilatation and impaired contraction of the left or both ventricles with normal wall thickness" . It is characterized by systolic dysfunction with reduced myocardial contractility . DCM is the third leading cause of heart failure in pediatrics 3. The exact etiology of DCM is unknown in more than half of the cases and the term idiopathic DCM is used after exclusion of all the well-known etiologies of DCM as viral infections, autoimmune, genetic, endocrinal, and metabolic diseases .

DCM is typically diagnosed when patients present with heart failure symptoms, typically related to left ventricle systolic dysfunction, but right systolic dysfunction may accompany left ventricle failure . About 8-15% of patients will present with cardiac arrest, or with near-arrest requiring emergent resuscitation. In the remainder of patients, the most common symptom is shortness of breath (50%), followed by gastrointestinal upset and fatigue that is reported in a third of patients. Symptoms of an upper respiratory tract infection are also common. Echocardiography is the gold standard for diagnosis of DCM .

Methods:

All patients in this study will be subjected to the following (as detailed in the attached patient's data sheet).

  1. Clinical History: focusing on:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
1 Year 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged 1 to 12 years diagnosed with dilated cardiomyopathy by Echocardiography.
  • Control: Age and sex match children attending Pediatric cardiology clinic with acute non serious illness to be included as Control

排除标准

  • Other types of cardiomyopathy (As hypertrophic, restrictive cardiomyopathy and other types).
  • Dilatation of Left ventricle due to other congenital or rheumatic heart diseases

研究组 & 干预措施

Case Group.

Experimental

Children aged 1 to 12 years diagnosed with dilated cardiomyopathy (DCM) by Echocardiography.

干预措施: Echocardiography assessment. (Diagnostic Test)

Case Group.

Experimental

Children aged 1 to 12 years diagnosed with dilated cardiomyopathy (DCM) by Echocardiography.

干预措施: Laboratory investigations and Hormone assessment. (Diagnostic Test)

Control Group.

Experimental

Age and sex matched children with acute non-serious illnesses.

干预措施: Laboratory investigations and Hormone assessment. (Diagnostic Test)

研究者

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

Norhan Elsayed Abdellah

Pediatric resident at Sohag University Hospital

Sohag University

研究点 (1)

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