Hypothyroidism With Congenital Heart Disease (CHD)

Hypothyroidism Clinical Trial

Official title:

Evaluation of Thyroid Function in Children With Congenital Heart Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03496363
• Other study ID #: CHD
• Status: Not yet recruiting
• First received: March 10, 2018
• Last updated: April 5, 2018
• Start date: May 1, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: April 2018
• Source: Assiut University
• Contact: Nagwa Ali Mohamed, Professor
• Phone: 01096260950
• Email: Nagwa.Abdelaal[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• CHD
• Heart Defects, Congenital
• Heart Diseases
• Hypothyroidism

Intervention

Diagnostic Test:
• TSH , T4
Thyroid stimulating hormone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (11)

Ahmet A, Lawson ML, Babyn P, Tricco AC. Hypothyroidism in neonates post-iodinated contrast media: a systematic review. Acta Paediatr. 2009 Oct;98(10):1568-74. doi: 10.1111/j.1651-2227.2009.01412.x. Epub 2009 Jul 3. Review. — View Citation

American Academy of Pediatrics, Rose SR; Section on Endocrinology and Committee on Genetics, American Thyroid Association, Brown RS; Public Health Committee, Lawson Wilkins Pediatric Endocrine Society, Foley T, Kaplowitz PB, Kaye CI, Sundararajan S, Varma SK. Update of newborn screening and therapy for congenital hypothyroidism. Pediatrics. 2006 Jun;117(6):2290-303. Review. — View Citation

Barr ML, Chiu HK, Li N, Yeh MW, Rhee CM, Casillas J, Iskander PJ, Leung AM. Thyroid Dysfunction in Children Exposed to Iodinated Contrast Media. J Clin Endocrinol Metab. 2016 Jun;101(6):2366-70. doi: 10.1210/jc.2016-1330. Epub 2016 Mar 28. — View Citation

Grüters A, Krude H. Detection and treatment of congenital hypothyroidism. Nat Rev Endocrinol. 2011 Oct 18;8(2):104-13. doi: 10.1038/nrendo.2011.160. Review. — View Citation

Lee SY, Rhee CM, Leung AM, Braverman LE, Brent GA, Pearce EN. A review: Radiographic iodinated contrast media-induced thyroid dysfunction. J Clin Endocrinol Metab. 2015 Feb;100(2):376-83. doi: 10.1210/jc.2014-3292. Epub 2014 Nov 6. Review. — View Citation

Léger J, Larroque B, Norton J; Association Française pour le Dépistage et la Prévetion des Handicaps de l'Enfant. Influence of severity of congenital hypothyroidism and adequacy of treatment on school achievement in young adolescents: a population-based cohort study. Acta Paediatr. 2001 Nov;90(11):1249-56. — View Citation

Oerbeck B, Sundet K, Kase BF, Heyerdahl S. Congenital hypothyroidism: influence of disease severity and L-thyroxine treatment on intellectual, motor, and school-associated outcomes in young adults. Pediatrics. 2003 Oct;112(4):923-30. — View Citation

Olivieri A, Stazi MA, Mastroiacovo P, Fazzini C, Medda E, Spagnolo A, De Angelis S, Grandolfo ME, Taruscio D, Cordeddu V, Sorcini M; Study Group for Congenital Hypothyroidism. A population-based study on the frequency of additional congenital malformations in infants with congenital hypothyroidism: data from the Italian Registry for Congenital Hypothyroidism (1991-1998). J Clin Endocrinol Metab. 2002 Feb;87(2):557-62. — View Citation

Passeri E, Frigerio M, De Filippis T, Valaperta R, Capelli P, Costa E, Fugazzola L, Marelli F, Porazzi P, Arcidiacono C, Carminati M, Ambrosi B, Persani L, Corbetta S. Increased risk for non-autoimmune hypothyroidism in young patients with congenital heart defects. J Clin Endocrinol Metab. 2011 Jul;96(7):E1115-9. doi: 10.1210/jc.2011-0057. Epub 2011 Apr 27. — View Citation

Rastogi MV, LaFranchi SH. Congenital hypothyroidism. Orphanet J Rare Dis. 2010 Jun 10;5:17. doi: 10.1186/1750-1172-5-17. Review. — View Citation

Toscano E, Pacileo G, Limongelli G, Verrengia M, Di Mita O, Di Maio S, Salerno M, Del Giudice E, Caniello B, Calabrò R, Andria G. Subclinical hypothyroidism and Down's syndrome; studies on myocardial structure and function. Arch Dis Child. 2003 Nov;88(11):1005-8. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EVALUATE THYROID FUNCTION IN PATIENTS WITH CONGENITAL HEART DISEASE	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	Detect the percentage of patients with congenital heart disease and have no thyroid problems	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