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Clinical Trials/NCT07567417
NCT07567417Not yet recruitingNot Applicable

Endocrinal Dysfunction Among Children With Dilated Cardiomyopathy at Sohag University Hospital

Sohag University1 site in 1 country100 target enrollmentStarted: June 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
100
Locations
1

Study Overview

Brief Summary

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

Detailed Description

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:

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
1 Year to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

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

Arms & Interventions

Case Group.

Experimental

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

Intervention: Echocardiography assessment. (Diagnostic Test)

Case Group.

Experimental

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

Intervention: Laboratory investigations and Hormone assessment. (Diagnostic Test)

Control Group.

Experimental

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

Intervention: Laboratory investigations and Hormone assessment. (Diagnostic Test)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Norhan Elsayed Abdellah

Pediatric resident at Sohag University Hospital

Sohag University

Study Sites (1)

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