Levothyroxine for heart function in children with subclinical hypothyroidism
Official title: The Effect of Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism
Run by Tanta University · NCT07393165 · Data updated 2026-11-12
This trial will test whether levothyroxine improves heart function in children aged 4–15 who have subclinical hypothyroidism.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 15 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Status | Recruiting |
| Started | May 24, 2025 |
| Main results expected | May 1, 2026 |
| Study ends | May 1, 2026 |
| Registry record updated | February 6, 2026 |
| Trial ID | NCT07393165 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Some adult studies report modest cardiac improvements with levothyroxine in subclinical hypothyroidism, but pediatric data are limited and results have been mixed.
Who can join: the full rules
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 it's running
-
Tanta University
Tanta, El-Gharbia, Egypt Recruiting
Study contacts
- Study coordinator: Zeinab E Elshareef, MBBCH
- Email: zeinabibraheem26@gmail.com
- Phone: 00201001700194
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.