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Endocrinal Dysfunction Among Children With Dilated Cardiomyopathy

3 de mayo de 2026 actualizado por: Norhan Elsayed Abdellah, Sohag University

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

Descripción general del estudio

Descripción detallada

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.)

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Sohag, Egipto
        • Pediatric department at Sohag University hospital
        • Contacto:
          • Nourhan Elsayed
          • Número de teléfono: 01122317103

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Case Group.
Children aged 1 to 12 years diagnosed with dilated cardiomyopathy (DCM) by Echocardiography.
Assessment of Ejection fraction, Fractional shortening, and LV diameters/volumes to confirm diagnosis and severity.
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.
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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Assessment of endocrine parameters in children with dilated cardiomyopathy
Periodo de tiempo: One year
Insulin growth factor to be withdrawn from patient with dilated cardiomyopathy by venipuncture
One year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

10 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de mayo de 2026

Publicado por primera vez (Actual)

5 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Soh-Med-25-10-10MS

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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