Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: L-thyroxine.
- Who it may be relevant to
- Registry conditions: Levothyroxine, Cardiac Function, Children, Subclinical Hypothyroidism. Basic parameters: 4 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism
Overview
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
- Drug L-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.
Primary outcome measures
- Assessment of left ventricle systolic function [Time frame: 3 months post-procedure]
Secondary outcome measures (1)
- Assessment of left ventricle fractional shortening [Time frame: 3 months post-procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07393165 · 36264MS959/5/25