Hypothyroidism With Congenital Heart Disease (CHD)

• Conditions: Hypothyroidism; CHD
• Interventions: Diagnostic Test: TSH , T4

• Registration Number: NCT03496363
• Lead Sponsor: Assiut University

Brief Summary

Congenital hypothyroidism is one of the most preventable causes of neurocognitive impairment because early treatment is possible in neonates. The thyroid hormone is important for normal growth and development in infancy. After introducing national screening test using capillary thyroid stimulating hormone level, the incidence of untreated congenital hypothyroidism has significantly decreased.

According to the Italian Registry of Congenital Hypothyroidism, congenital heart disease is the most frequent disease condition associated with congenital hypothyroidism.

Congenital heart disease is also reported to be a risk factor for non-autoimmune hypothyroidism in children. In addition, intravenous iodine contrast media is frequently used for diagnostic imaging and therapeutic intervention in congenital heart disease patients. Excess iodine exposed by iodine contrast media may disturb thyroid function in adult and pediatric population. However, there is no generally accepted guideline for screening thyroid dysfunction in congenital heart disease infants.

An increased prevalence of thyroid disease, particularly sub-clinical hypothyroidism, has been reported in Down Syndrome. In children with Down Syndrome, a possible concomitant sub-clinical hypothyroidism-related impairment of cardiac function or structure may worsen their clinical condition and can ultimately affect their life expectancy.

Detailed Description

Aim of the work :

The aim of the work is to assess the thyroid function in children with congenital heart disease.

Inclusion criteria :

Patients with congenital heart diseases from birth (full term) to 3 years.

Exclusion criteria :

Patients with cardiac disease other than congenital heart disease. Preterm infants. Patients with other non cardiac congenital anomalies. Other endocrinal or central nervous system dysfunction. Maternal history of thyroid disease or antithyroid management.

Methods :

The study will be conducted in the Cardiology or Neonatology Units , Children's University Hospital, Faculty of Medicine, Assiut University on 50 patients both males and females.

All children will be evaluated by thoroughly history taken. Full general (including the anthropometric measures) and cardiac examinations will be done.

The patients will be conducted to investigations as:

Thyroid function tests. Electrocardiograph. X-ray chest and heart. Echocardiography.

Ethical considerations:

1. Risk benefit assessment, All patients will not be subjected to risk of any kind during this study.

2. Confidentiality, All patient's data will be confidential and stored in a secure location.

3. Informed consent, An informed consent will be taken from all patients and included.

4. Other ethical consideration, The research will be conducted only by scientifically qualified and trained personnel

Study Timeline

• Study First Submitted: 2018-03-10
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-05
• Last Update Submitted: 2018-04-05
• Study First Posted: 2018-04-12
• Last Update Posted: 2018-04-12
• Study Start: 2018-05-01
• Primary Completion: 2019-05-01
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with congenital heart diseases from birth (full term) to 3 years

Read More

Exclusion Criteria

• Patients with cardiac disease other than congenital heart disease
• Preterm infants
• Patients with other non cardiac congenital anomalies
• Other endocrinal or CNS dysfunction
• Maternal history of thyroid disease or antithyroid management

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CHD with Hypothyroidism	TSH , T4	-

Primary Outcome Measures

Name	Time	Method
EVALUATE THYROID FUNCTION IN PATIENTS WITH CONGENITAL HEART DISEASE	May 2018 - May 2020	The study include evaluation of Thyroid function in patients with congenital heart disease coming to cardiology unit - pediatric hospital - Assiut University by measuring TSH and T4 level and detect percentage of hypothyroidism in patients with congenital heart disease.

Secondary Outcome Measures

Name	Time	Method
Detect the percentage of patients with congenital heart disease and have no thyroid problems	May 2018 - May 2020	If TSH and T4 level in patients with congenital heart disease is in normal value , then detect the percentage of patients with congenital heart disease and have no thyroid problems.