Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-15
SponsorTanta University
About this trial
This study aims to evaluate the effect of the treatment with levothyroxine on cardiac function in children with subclinical hypothyroidism.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Overweight and obesity
Hypertension
Previous use of levothyroxine, antiepileptic drugs, or cardiac drugs within the last 6 months.
Arrhythmia.
Trial design
Design model
Parallel
Treatments tested in this trial
L-thyroxine
DrugChildren 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Treatment groupExperimental treatment 1 intervention
Group B: No treatment groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months post-procedureSecondary outcomes
1
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.
Time frame
3 months post-procedureSponsors and contacts
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Source ClinicalTrials.gov