Endocrinal Dysfunction Among Children With Dilated Cardiomyopathy

NCT07567417 | Not Yet Recruiting DMC

• 1 other identifier: Soh-Med-25-10-10MS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

• 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.
• 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).
• Severity of heart failure in children with dilated cardiomyopathy For all patients, they were classified according to Children's Ross HF classification.
• Data collection: according to attached checklist for every patient involved in the study

Conditions

Assessment of Some Hormone Levels in Children With Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Assessment of endocrine parameters in children with dilated cardiomyopathy

  Insulin growth factor to be withdrawn from patient with dilated cardiomyopathy by venipuncture

  One year

Study Arms (2)

Case Group.

EXPERIMENTAL

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

Diagnostic Test: Echocardiography assessment.; Diagnostic Test: Laboratory investigations and Hormone assessment.

Control Group.

EXPERIMENTAL

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

Diagnostic Test: Laboratory investigations and Hormone assessment.

Interventions

Echocardiography assessment. DIAGNOSTIC_TEST

Assessment of Ejection fraction, Fractional shortening, and LV diameters/volumes to confirm diagnosis and severity.

Case Group.

Laboratory investigations and Hormone assessment. DIAGNOSTIC_TEST

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).

Case Group.; Control Group.

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Pediatric department at Sohag University hospital

Sohag, Egypt

Location

Central Study Contacts

Nourhan Elsayed, Pediatric resident at Sohag Un

CONTACT

01122317103; norhan.elsayed@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric resident at Sohag University Hospital

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)