The Effect of Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment of left ventricle systolic function
研究概览
简要总结
This study aims to evaluate the effect of the treatment with levothyroxine on cardiac function in children with subclinical hypothyroidism.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Infectious diseases
- •Respiratory diseases
- •Malignancies
研究组 & 干预措施
Treatment group
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.
干预措施: L-thyroxine (Drug)
No treatment group
Children with subclinical hypothyroidism who will receive no treatment.
结局指标
主要结局
Assessment of left ventricle systolic function
时间窗: 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.
次要结局
- Assessment of left ventricle fractional shortening(3 months post-procedure)
研究者
Zeinab Ebraheem Amin Elshareef
Resident of Pediatrics, Tanta University, Tanta, Egypt.
Tanta University