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Assessment of Some Hormone Levels in Children With Dilated CardiomyopathyNCT07567417

Endocrinal Dysfunction Among Children With Dilated Cardiomyopathy

A study testing Echocardiography assessment. and Laboratory investigations and Hormone assessment. in people with Assessment of Some Hormone Levels in Children With Dilated Cardiomyopathy, run by Sohag University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 12 yearsHealthy volunteers can take part
What is being tested?
Echocardiography assessment. and Laboratory investigations and Hormone assessment.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Jun 2026to 1 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nourhan Elsayed, Pediatric resident at Sohag Un contact

01122317103

norhan.elsayed@med.sohag.edu.eg

Egypt1 site
  • Pediatric department at Sohag University hospital

    Sohag

    Nourhan Elsayed, 01122317103

Other trials in Egypt

About this study

Official title: 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:
Read more
  • 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.
  2. Data collection: according to attached checklist for every patient involved in the study
Read the 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.
  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.
  2. Data collection: according to attached checklist for every patient involved in the study
  3. 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
  1. Possible Therapeutic Modalities given to patients in the study Medical treatment (e.g .Anti-failure medications: Diuretics, ACE inhibitors,..etc.)
Being tested
Echocardiography assessment., Laboratory investigations and Hormone assessment.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Echocardiography assessment.Diagnostic test

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

  • 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).

Study groups in NCT07567417
Study groupRoleWhat they receive
Case Group.ExperimentalChildren aged 1 to 12 years diagnosed with dilated cardiomyopathy (DCM) by Echocardiography.
Receives: Diagnostic Test: Echocardiography assessment.; Diagnostic Test: Laboratory investigations and Hormone assessment.
Control Group.ExperimentalAge and sex matched children with acute non-serious illnesses.
Receives: Diagnostic Test: Laboratory investigations and Hormone assessment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of endocrine parameters in children with dilated cardiomyopathy

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

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07567417
Sponsor's protocol ID
Soh-Med-25-10-10MS
Status last verified
May 2026
First submitted
10 Mar 2026
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Echocardiography assessment. and Laboratory investigations and Hormone assessment. in people with Assessment of Some Hormone Levels in Children With Dilated Cardiomyopathy, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nourhan Elsayed, Pediatric resident at Sohag Un (01122317103, norhan.elsayed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of endocrine parameters in children with dilated cardiomyopathy (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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