Cardiac Function, Children, Levothyroxine, Subclinical Hypothyroidism
Conditions
Brief summary
This study aims to evaluate the effect of the treatment with levothyroxine on cardiac function in children with subclinical hypothyroidism.
Detailed description
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.
Interventions
DRUGL-thyroxine
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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Age from 4 to 15 years. * Both sexes. * Patients with stable elevated thyroid-stimulating hormone (TSH) ≥ 4.5 mIU/L with normal free T4 and ft3 in different measurement 4 - 6 weeks apart.
Exclusion criteria
* Overweight and obesity * Hypertension * Previous use of levothyroxine, antiepileptic drugs, or cardiac drugs within the last 6 months. * Arrhythmia. * Congenital or acquired heart disease * Liver or kidney disease * Hyperlipidemia * Diabetes * Infectious diseases * Respiratory diseases * Malignancies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of left ventricle systolic function | 3 months post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of left ventricle fractional shortening | 3 months post-procedure | 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. |
Countries
Egypt
Contacts
CONTACTZeinab E Elshareef, MBBCH
Outcome results
None listed