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.
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
- Conditions the study is for
- Assessment of Some Hormone Levels in Children With Dilated Cardiomyopathy
- 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.
Egypt1 site
Pediatric department at Sohag University hospital
Sohag
Nourhan Elsayed, 01122317103
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).
- 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.
- 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. 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.
- 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).
- 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.
- 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. 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.
- Data collection: according to attached checklist for every patient involved in the study
- 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
- 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 group | Role | What they receive |
|---|---|---|
| Case Group. | Experimental | Children 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. | Experimental | Age 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.
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.
- First posted5 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of Some Hormone Levels in Children With Dilated CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhan Elsayed Abdellah, Sohag University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrinal Dysfunction Among Children With Dilated Cardiomyopathy at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT07567417
- Acronym / sponsor ID
- Soh-Med-25-10-10MS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All patients in this study will be subjected to the following (as detailed in the attached patient's data sheet).
- 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.
- 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. 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.
- 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).
- 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.
- 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. 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.
- Data collection: according to attached checklist for every patient involved in the study
- 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
- Possible Therapeutic Modalities given to patients in the study Medical treatment (e.g .Anti-failure medications: Diuretics, ACE inhibitors,..etc.)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group. | Experimental | Diagnostic Test: Echocardiography assessment., Diagnostic Test: Laboratory investigations and Hormone assessment.Children aged 1 to 12 years diagnosed with dilated cardiomyopathy (DCM) by Echocardiography. |
| Control Group. | Experimental | Diagnostic Test: Laboratory investigations and Hormone assessment.Age and sex matched children with acute non-serious illnesses. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Other types of cardiomyopathy (As hypertrophic, restrictive cardiomyopathy and other types).
- Dilatation of Left ventricle due to other congenital or rheumatic heart diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography assessment.Assessment of Ejection fraction, Fractional shortening, and LV diameters/volumes to confirm diagnosis and severity. | Diagnostic test | Case Group. |
| 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). | Diagnostic test | Case Group., Control Group. |
Primary outcome
Assessment of endocrine parameters in children with dilated cardiomyopathy
Time frame: One year
Insulin growth factor to be withdrawn from patient with dilated cardiomyopathy by venipuncture
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.