Levothyroxine for heart function in children with subclinical hypothyroidism
The Effect of Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism
This trial will test whether levothyroxine improves heart function in children aged 4–15 who have subclinical hypothyroidism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 4 Years to 15 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT07393165 on ClinicalTrials.gov |
What this trial studies
Children with subclinical hypothyroidism (elevated TSH with normal free T4 and FT3) will receive levothyroxine and undergo repeated cardiac evaluations to see how treatment affects heart function. Eligibility requires stable elevated TSH (≥4.5 mIU/L) confirmed 4–6 weeks apart and excludes obesity, hypertension, prior thyroid or cardiac drug use, and known heart, liver, kidney, metabolic, infectious, respiratory, or malignant disease. Cardiac outcomes will be monitored with clinical exams and imaging or functional cardiac tests at the treating center, alongside thyroid function monitoring. The intervention is administered at Tanta University and follows an interventional protocol to compare pre- and post-treatment cardiac measures.
Who should consider this trial
Good fit: Children aged 4 to 15 with stable elevated TSH (≥4.5 mIU/L) and normal free T4 and FT3 on repeat testing, who do not meet any exclusion criteria, are ideal candidates.
Not a fit: Children with obesity, hypertension, known arrhythmia or congenital/acquired heart disease, prior recent levothyroxine or relevant medication use, or significant systemic illnesses are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, treatment could improve cardiac function and reduce early cardiovascular risk markers in affected children.
How similar studies have performed: Some adult studies report modest cardiac improvements with levothyroxine in subclinical hypothyroidism, but pediatric data are limited and results have been mixed.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Zeinab E Elshareef, MBBCH
- Email: zeinabibraheem26@gmail.com
- Phone: 00201001700194
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.