Hypothyroidism With Congenital Heart Disease (CHD)

April 5, 2018 updated by: Marwa M Atteya, Assiut University

Evaluation of Thyroid Function in Children With Congenital Heart Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with congenital heart disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CHD with Hypothyroidism
Diagnostic test: TSH , T4
Thyroid stimulating hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
May 2018 - May 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
May 2018 - May 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

March 10, 2018

First Submitted That Met QC Criteria

April 5, 2018

First Posted (Actual)

April 12, 2018

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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