- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07567417
Endocrinal Dysfunction Among Children With Dilated Cardiomyopathy
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:
- 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
Обзор исследования
Статус
Подробное описание
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.)
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Nourhan Elsayed, Pediatric resident at Sohag Un
- Номер телефона: 01122317103
- Электронная почта: norhan.elsayed@med.sohag.edu.eg
Места учебы
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-
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Sohag, Египет
- Pediatric department at Sohag University hospital
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Контакт:
- Nourhan Elsayed
- Номер телефона: 01122317103
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Нерандомизированный
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Case Group.
Children aged 1 to 12 years diagnosed with dilated cardiomyopathy (DCM) by Echocardiography.
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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).
|
|
Экспериментальный: 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).
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Assessment of endocrine parameters in children with dilated cardiomyopathy
Временное ограничение: One year
|
Insulin growth factor to be withdrawn from patient with dilated cardiomyopathy by venipuncture
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One year
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- Soh-Med-25-10-10MS
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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