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Not yet recruiting NCT07567417

Endocrinal Dysfunction Among Children With Dilated Cardiomyopathy

No phase Interventional Assessment of Some Hormone Levels in Children With Dilated Cardiomyopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Echocardiography assessment., Laboratory investigations and Hormone assessment..
Who it may be relevant to
Registry conditions: Assessment of Some Hormone Levels in Children With Dilated Cardiomyopathy. Basic parameters: 1 year — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Endocrinal Dysfunction Among Children With Dilated Cardiomyopathy at Sohag University Hospital

Overview

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

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.)

Interventions

  • 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).

Primary outcome measures

  • Assessment of endocrine parameters in children with dilated cardiomyopathy [Time frame: One year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Egypt · 1 center
  • Pediatric department at Sohag University hospital — Sohag

Identifiers

NCT: NCT07567417 · Soh-Med-25-10-10MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗