COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Hypothyroidism With Congenital Heart Disease (CHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03496363
Recruitment Status : Not yet recruiting
First Posted : April 12, 2018
Last Update Posted : April 12, 2018
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

Layout table for study information
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 :
    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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

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 identifier (NCT number): NCT03496363

Layout table for location contacts
Contact: Nagwa Ali Mohamed, Professor 01096260950
Contact: Mohamed El Ameer Fathy Riad, Assisstant Professor 01005689353

Sponsors and Collaborators
Assiut University


Layout table for additonal information
Responsible Party: Marwa M Atteya, Principal investigator, Assiut University Identifier: NCT03496363    
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

Layout table for additional information
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:
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Cardiovascular Diseases
Thyroid Diseases
Endocrine System Diseases