HypothyroidismNCT03496363
Hypothyroidism With Congenital Heart Disease (CHD)
An observational study of Hypothyroidism and CHD, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 1 day to 3 years
- Conditions the study is for
- Hypothyroidism, CHD
- What is being tested?
- TSH , T4
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with congenital heart disease
Who may be able to join
- Patients with congenital heart diseases from birth (full term) to 3 years
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
Read the 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:
- Risk benefit assessment, All patients will not be subjected to risk of any kind during this study.
- Confidentiality, All patient's data will be confidential and stored in a secure location.
- Informed consent, An informed consent will be taken from all patients and included.
- Other ethical consideration, The research will be conducted only by scientifically qualified and trained personnel
- Conditions
- Hypothyroidism, CHD
- Being tested
- TSH , T4
- Keywords
- Children
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSH , T4Diagnostic test
Thyroid stimulating hormone
| Study group | Role | What they receive |
|---|---|---|
| CHD with Hypothyroidism | Not described Receives: Diagnostic Test: TSH , T4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: May 2018 - May 2020
Secondary outcomes (1)
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.
Measured: May 2018 - May 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa M Atteya, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496363
- Sponsor's protocol ID
- CHD
- Status last verified
- Apr 2018
- First submitted
- 10 Mar 2018
- Last updated
- 12 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gruters 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.
PubMed 22009163Rastogi MV, LaFranchi SH. Congenital hypothyroidism. Orphanet J Rare Dis. 2010 Jun 10;5:17. doi: 10.1186/1750-1172-5-17.
PubMed 20537182Oerbeck 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. doi: 10.1542/peds.112.4.923.
PubMed 14523187Leger J, Larroque B, Norton J; Association Francaise pour le Depistage et la Prevetion 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. doi: 10.1111/j.1651-2227.2001.tb01570.x.
PubMed 11808894American 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. doi: 10.1542/peds.2006-0915.
PubMed 16740880Olivieri 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. doi: 10.1210/jcem.87.2.8235.
PubMed 11836285Passeri 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.
PubMed 21525159Barr 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.
PubMed 27018967Ahmet 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.
PubMed 19575766Lee 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.
PubMed 25375985Toscano E, Pacileo G, Limongelli G, Verrengia M, Di Mita O, Di Maio S, Salerno M, Del Giudice E, Caniello B, Calabro R, Andria G. Subclinical hypothyroidism and Down's syndrome; studies on myocardial structure and function. Arch Dis Child. 2003 Nov;88(11):1005-8. doi: 10.1136/adc.88.11.1005.
PubMed 14612370
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thyroid Function in Children With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT03496363
- Acronym / sponsor ID
- CHD
- Conditions
- Hypothyroidism, CHD
- Keywords
- Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Risk benefit assessment, All patients will not be subjected to risk of any kind during this study.
- Confidentiality, All patient's data will be confidential and stored in a secure location.
- Informed consent, An informed consent will be taken from all patients and included.
- Other ethical consideration, The research will be conducted only by scientifically qualified and trained personnel
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHD with Hypothyroidism | – | Diagnostic Test: TSH , T4 |
Who may qualify
- Ages
- 1 day to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with congenital heart disease
Key inclusion criteria (1 listed)
- Patients with congenital heart diseases from birth (full term) to 3 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSH , T4Thyroid stimulating hormone | Diagnostic test | CHD with Hypothyroidism |
Primary outcome
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.
1 secondary outcome
Detect the percentage of patients with congenital heart disease and have no thyroid problems
Time frame: May 2018 - May 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Background: PubMed 22009163Gruters 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.
- Background: PubMed 20537182Rastogi MV, LaFranchi SH. Congenital hypothyroidism. Orphanet J Rare Dis. 2010 Jun 10;5:17. doi: 10.1186/1750-1172-5-17.
- Background: PubMed 14523187Oerbeck 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. doi: 10.1542/peds.112.4.923.
- Background: PubMed 11808894Leger J, Larroque B, Norton J; Association Francaise pour le Depistage et la Prevetion 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. doi: 10.1111/j.1651-2227.2001.tb01570.x.
- Background: PubMed 16740880American 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. doi: 10.1542/peds.2006-0915.
- Background: PubMed 11836285Olivieri 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. doi: 10.1210/jcem.87.2.8235.
- Background: PubMed 21525159Passeri 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.
- Background: PubMed 27018967Barr 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.
- Background: PubMed 19575766Ahmet 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.
- Background: PubMed 25375985Lee 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.
- Background: PubMed 14612370Toscano E, Pacileo G, Limongelli G, Verrengia M, Di Mita O, Di Maio S, Salerno M, Del Giudice E, Caniello B, Calabro R, Andria G. Subclinical hypothyroidism and Down's syndrome; studies on myocardial structure and function. Arch Dis Child. 2003 Nov;88(11):1005-8. doi: 10.1136/adc.88.11.1005.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism and CHD, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nagwa Ali Mohamed, Professor (01096260950, Nagwa.Abdelaal@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EVALUATE THYROID FUNCTION IN PATIENTS WITH CONGENITAL HEART DISEASE (time frame: May 2018 - May 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03496363, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.