Endocrinal Dysfunction Among Children With Dilated Cardiomyopathy

Endocrinal Dysfunction Among Children With Dilated Cardiomyopathy at Sohag University Hospital

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.

2. 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).

3. 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

Study Overview

• Status: Not yet recruiting
• Conditions: Assessment of Some Hormone Levels in Children With Dilated Cardiomyopathy
• Intervention / Treatment: Diagnostic test: Echocardiography assessment.; Diagnostic test: Laboratory investigations and Hormone assessment.

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:

   • 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.

2. 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).

3. 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

5. Investigations: focusing on

   • Laboratory investigations (IGF-1, free T3 and T4, TSH, morning serum cortisol and ACTH, 25 OH vit D, total and ionized calcium, serum parathyroid hormones levels, serum prolactin, serum electrolytes as Na, K). Samples to be withdrawn from cases and controls at 9:00 a.m. at the Pediatric Cardiology Unit, Sohag University Hospital.
   • Echocardiography assessment including:

   Ejection fraction

   Fractional shortening

   Left ventricular end systolic diameter

   Left ventricular end diastolic diameter

   Mitral valve closure to opening time

   Left ventricular ejection time

   Mitral valve ejection

   Mitral valve area

   E/A ratio Mitral valve

   Myocardial performance index of Left ventricular

6. Possible Therapeutic Modalities given to patients in the study Medical treatment (e.g .Anti-failure medications: Diuretics, ACE inhibitors,..etc.)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nourhan Elsayed, Pediatric resident at Sohag Un; Phone Number: 01122317103; Email: norhan.elsayed@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Pediatric department at Sohag University hospital
    • Contact: Nourhan Elsayed; Phone Number: 01122317103

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case Group.; Children aged 1 to 12 years diagnosed with dilated cardiomyopathy (DCM) by Echocardiography.	Diagnostic test: Echocardiography assessment.; Assessment of Ejection fraction, Fractional shortening, and LV diameters/volumes to confirm diagnosis and severity.; Diagnostic test: Laboratory investigations and Hormone assessment.; Blood samples will be collected at 9:00 a.m. to measure IGF-1, free T3 and T4, TSH, morning serum cortisol, ACTH, 25 OH vit D, calcium, parathyroid hormones, prolactin, and electrolytes (Na, K).
Experimental: Control Group.; Age and sex matched children with acute non-serious illnesses.	Diagnostic test: Laboratory investigations and Hormone assessment.; Blood samples will be collected at 9:00 a.m. to measure IGF-1, free T3 and T4, TSH, morning serum cortisol, ACTH, 25 OH vit D, calcium, parathyroid hormones, prolactin, and electrolytes (Na, K).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of endocrine parameters in children with dilated cardiomyopathy	Insulin growth factor to be withdrawn from patient with dilated cardiomyopathy by venipuncture	One year

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: May 3, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med-25-10-10MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No