Hypothyroidism With Congenital Heart Disease (CHD)

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03496363
Collaborator
(none)
50
24

Study Details

Study Description

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 Phase
  • 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

Study Design

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

Arms and Interventions

Arm Intervention/Treatment
CHD with Hypothyroidism

Diagnostic Test: TSH , T4
Thyroid stimulating hormone

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 3 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Marwa M Atteya, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03496363
Other Study ID Numbers:
  • CHD
First Posted:
Apr 12, 2018
Last Update Posted:
Apr 12, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marwa M Atteya, Principal investigator, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2018