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This study aims to evaluate the effect of the treatment with levothyroxine on cardiac function in children with subclinical hypothyroidism.
Subclinical hypothyroidism (SH) is a branch of hypothyroidism which is characterized by increased thyroid stimulating hormone (TSH) and normal thyroxine (T4).
Inadequate serum thyroid hormone levels impair cardiac function and may result in multiple cardiovascular risk factors, such as endothelial dysfunction, increased intima-media thickness, increased vascular resistance, and pericardial effusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Children with subclinical hypothyroidism who will receive L-thyroxine treatment in a dose of 2μg/kg/d (the smallest dose can be given) and the dose will be titrated every 4 weeks until a normal thyroid-stimulating hormone (TSH) level is maintained. |
|
| No treatment group | No Intervention | Children with subclinical hypothyroidism who will receive no treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-thyroxine | Drug | Children with subclinical hypothyroidism who will receive L-thyroxine treatment in a dose of 2μg/kg/d (the smallest dose can be given) and the dose will be titrated every 4 weeks until a normal thyroid-stimulating hormone (TSH) level is maintained. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of left ventricle systolic function | Left ventricle systolic function will be measured using left ventricle (LV) ejection fraction (LV EF%) where: (LV EF%) = (LVEDD)³ - (LVESD) / (LVEDD)³×100% LVEDD=left ventricular end-diastolic dimension. LVESD=left ventricular end-systolic dimension. LVFS=LV fractional shortening. | 3 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of left ventricle fractional shortening | Left ventricle fractional shortening (LV FS) will be measured. where: LV FS= LVEDD-LVESD/LVEDD X 100%. LVEDD=left ventricular end-diastolic dimension. LVESD=left ventricular end-systolic dimension. | 3 months post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zeinab E Elshareef, MBBCH | Contact | 00201001700194 | zeinabibraheem26@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |