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Hypothyroidism With Congenital Heart Disease (CHD)

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ClinicalTrials.gov Identifier: NCT03496363
Recruitment Status : Not yet recruiting
First Posted : April 12, 2018
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Marwa M Atteya, 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.


Condition or disease Intervention/treatment
Hypothyroidism CHD Diagnostic Test: TSH , T4

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

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Thyroid Function in Children With Congenital Heart Disease
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CHD with Hypothyroidism Diagnostic Test: TSH , T4
Thyroid stimulating hormone




Primary Outcome Measures :
  1. EVALUATE THYROID FUNCTION IN PATIENTS WITH CONGENITAL HEART DISEASE [ Time Frame: 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 :
  1. Detect the percentage of patients with congenital heart disease and have no thyroid problems [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with congenital heart disease
Criteria

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 CNS dysfunction
  • Maternal history of thyroid disease or antithyroid management

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496363


Contacts
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Contact: Nagwa Ali Mohamed, Professor 01096260950 Nagwa.Abdelaal@med.au.edu.eg
Contact: Mohamed El Ameer Fathy Riad, Assisstant Professor 01005689353 mohamed_osman@med.au.edu.eg

Sponsors and Collaborators
Assiut University

Publications:

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Responsible Party: Marwa M Atteya, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03496363     History of Changes
Other Study ID Numbers: CHD
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marwa M Atteya, Assiut University:
Children

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Hypothyroidism
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Thyroid Diseases
Endocrine System Diseases